Treatment-related Side Effects Research Articles

Racial differences in familiarity, interest, and use of integrative medicine among patients with breast cancer.

Integrative medicine (IM) has received the American Society of Clinical Oncology's endorsement for managing cancer treatment-related side effects. Little is known about racial differences in familiarity, interest, and use of IM among patients with breast cancer. Patients with breast cancer enrolled in the Chicago Multiethnic Epidemiologic Breast Cancer Cohort were surveyed regarding familiarity, interest, and use of acupuncture, massage, meditation, music therapy, and yoga. Familiarity and interest, measured by a 5-point Likert scale, was modeled using proportional odds. Use was self-reported, and modeled using binary logistic regression. Of 1,300 respondents (71.4% White and 21.9% Black), Black patients were less likely than White patients to be familiar with acupuncture (aOR 0.60, 95% CI 0.41-0.87); there were no racial differences in familiarity with massage, meditation, music therapy, and yoga. While there were no differences in interest in acupuncture between Black and White patients (aOR 1.12, 95% CI 0.76-1.65), Black patients were more interested in massage (aOR 1.86, 95% CI 1.25-2.77), meditation (aOR 2.03, 95% CI 1.37-3.00), music therapy (aOR 2.68, 95% CI 1.80-3.99), and yoga (aOR 2.10, 95% CI 1.41-3.12). Black patients were less likely than White patients to have used acupuncture (aOR 0.49, 95% CI 0.29-0.84); but there were no racial differences in use of massage, meditation, music therapy, and yoga. Black patients expressed more interest in IM than their White counterparts; there were no racial differences in IM use, except lower acupuncture use among Black patients. A breast program focused on equity should provide access to these services for patients with breast cancer.

A Humanized and Viable Animal Model for Congenital Adrenal Hyperplasia–CYP21A2-R484Q Mutant Mouse

Congenital Adrenal Hyperplasia (CAH) is an autosomal recessive disorder impairing cortisol synthesis due to reduced enzymatic activity. This leads to persistent adrenocortical overstimulation and the accumulation of precursors before the blocked enzymatic step. The predominant form of CAH arises from mutations in CYP21A2, causing 21-hydroxylase deficiency (21-OHD). Despite emerging treatment options for CAH, it is not always possible to physiologically replace cortisol levels and counteract hyperandrogenism. Moreover, there is a notable absence of an effective in vivo model for pre-clinical testing. In this work, we developed an animal model for CAH with the clinically relevant point mutation p.R484Q in the previously humanized CYP21A2 mouse strain. Mutant mice showed hyperplastic adrenals and exhibited reduced levels of corticosterone and 11-deoxycorticosterone and an increase in progesterone. Female mutants presented with higher aldosterone concentrations, but blood pressure remained similar between wildtype and mutant mice in both sexes. Male mutant mice have normal fertility with a typical testicular appearance, whereas female mutants are infertile, exhibit an abnormal ovarian structure, and remain in a consistent diestrus phase. Conclusively, we show that the animal model has the potential to contribute to testing new treatment options and to prevent comorbidities that result from hormone-related derangements and treatment-related side effects in CAH patients.

Approach to weight management in patients with advanced chronic kidney disease in a real-life clinical setting.

Excess adiposity represents a risk factor for chronic kidney disease (CKD) and progression to end-stage kidney disease. Anti-Obesity Medications (AOMs) are vastly underutilized in patients with advanced CKD because of concerns related to safety and efficacy. This study was conducted to evaluate the real-world approach to weight management and the efficacy and safety of AOMs in people with advanced CKD. This is a retrospective analysis of individuals with Body Mass Index (BMI)≥27kg/m2 and eGFR≤30mL/min/1.73m2 referred to an academic medical weight-management program between 01/2015 and 09/2022. Evaluation of weight-management approaches, body weight change, treatment-related side effects, and reasons for treatment discontinuation were reported. Eighty-nine patients met inclusion criteria, 16 were treated with intensive lifestyle modifications (ILM) alone and 73 with AOMs (all treated with glucagon-like peptide-1 receptor agonist [GLP1-RA] +/- other AOMs) along with ILM. Patients treated with AOMs had a longer duration of on-treatment follow-up (median 924days) compared to (93days) the ILM group. Over 75% of patients treated with AOMs lost ≥5% body weight versus 25% of those treated with ILM. Only 15% of patients treated with AOMs discontinued therapy due to treatment-related side effects. In patients with obesity and advanced CKD, GLP-1RA-based anti-obesity treatment was well-tolerated, effective, and led to durable weight reduction.

Artificial intelligence- image learning and its applications in neurooncology: a review.

Image learning involves using artificial intelligence (AI) to analyse radiological images. Various machine and deeplearning- based techniques have been employed to process images and extract relevant features. These can later be used to detect tumours early and predict their survival based on their grading and classification. Radiomics is now also used to predict genetic mutations and differentiate between tumour progression and treatment-related side effects. These were once completely dependent on invasive procedures like biopsy and histopathology. The use and feasibility of these techniques are now widely being explored in neurooncology to devise more accurate management plans and limit morbidity and mortality. Hence, the future of oncology lies in the exploration of AI-based image learning techniques, which can be applied to formulate management plans based on less invasive diagnostic techniques, earlier detection of tumours, and prediction of prognosis based on radiomic features. In this review, we discuss some of these applications of image learning in current medical dynamics.

Exercise Therapy in Oncology—the Impact on Quality of Life and Side Effects.

The diagnosis and treatment of cancer are highly stressful. Exercise therapy is often used to mitigate the adverse effects of treatment. But how good is the evidence base, and what has changed in recent years? In this narrative review, we present the current data and what it implies for the care of adults with cancer. This review is based on data from meta-analyses and systematic reviews concerning 16 relevant clinical endpoints (outcomes) of exercise therapy for cancer patients The literature evaluated for this paper reveals that targeted exercise therapy is feasible and safe under appropriate supervision. It is highly effective for improving eight of the sixteen endpoints (anxiety, depression, fatigue, quality of life, physical function, secondary lymphedema after breast cancer, urinary incontinence, post-mastectomy pain syndrome in breast cancer) and may also have a beneficial effect on sleep quality, cardiotoxicity, and cognitive function. Less conclusive studies are currently available with respect to chemotherapy-induced polyneuropathy, nausea/vomiting, and bone health. There is currently insufficient data to suggest any benefit with respect to sexual function and frisk factors for falling. The data situation shows that exercise therapy for cancer patients is safe and has manifold effects on selected clinically relevant parameters. Further studies should be performed regarding the possible utility of exercise therapy against treatment-related side effects for which the evidence is currently insufficient. On the basis of the currently available and already existing recommendations, quality-assured exercise therapy can be recommended to cancer patients suffering from a wide range of neoplastic conditions.

Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study

Abstract INTRODUCTION: Patients with metastatic breast cancer (mBC) often experience cancer- and treatment-related side effects that can impair daily life activities and health-related quality of life (HRQoL). Interventions are needed that improve HRQoL by alleviating fatigue and other side effects during palliative BC cancer treatment. Recent evidence-based international guidelines (ASCO, ACSM) recommend exercise for patients with BC during adjuvant treatment for reducing side effects. However, evidence of the effectiveness of exercise in patients with mBC is scarce. The PREFERABLE-EFFECT study (NCT04120298) was designed to assess the effects of a 9-month supervised exercise program in patients with mBC on fatigue, HRQoL, and other cancer- and treatment-related side effects. METHODS: PREFERABLE-EFFECT is a multinational, randomized controlled trial including patients with mBC from five European countries (Germany, Poland, Spain, Sweden, The Netherlands) and Australia. Participants were randomly assigned to usual care or an individualized, structured exercise program consisting of aerobic, resistance, and balance training. The first six months included twice weekly supervised exercise sessions of one hour. In the last three months, one supervised session was replaced by an unsupervised session, supplemented by an exercise App. All participants received general exercise advice (physical activity ≥ 30 min/day) and an activity tracker. Our primary outcomes, physical fatigue (subscale of the EORTC QLQ-FA12) and HRQoL (summary score of the EORTC QLQ-C30), were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. The intervention effects (intention-to-treat) were determined by comparing the change from baseline to 3, 6 (i.e., primary endpoint) and 9 months between groups using separate mixed models for repeated measures, adjusted for baseline values of the outcome variable and stratification factors (mBC line of treatment (1st/2nd vs. 3rd or higher) and study center). A significant improvement of either or both primary outcomes (applying the Bonferroni-Holm method) was considered as successful. RESULTS: Between 2019-2022, we included 357 patients with mBC, with 178 patients randomized to the exercise intervention and 179 to usual care. Patients were, on average, 55.4 years of age (SD=11.1), most patients received 1st or 2nd line of treatment at study enrollment (74.8%) and had bone metastases (73.9%). At 6 months (primary endpoint), participation in the exercise intervention resulted in statistically significant positive effects on both primary outcomes, compared to usual care: physical fatigue was lower (mean difference: -5.3, 95% CI -10.0; -0.6, p=0.027, effect size (ES)=0.22) and HRQoL was better (+4.8, 95% CI 2.2; 7.4, p=0.0003, ES=0.33). Beneficial effects were also found at 3 months (physical fatigue: -3.4, -7.8; 1.0, ES=0.14 and QoL: 3.9, 1.5; 6.3, ES=0.27) and 9 months (physical fatigue: -5.6, -10.9; -0.4, ES=0.24 and QoL: +4.3, 1.4; 7.3, ES=0.31). Further, at the primary endpoint, we found positive exercise effects on physical fitness (+24.3 Watts, 15.5; 33.1, ES=0.42) and numerous QLQ-C30 scales, including social functioning (+5.5, 0.2; 10.8, ES=0.20), pain (-7.1, -12.1; -1.9, ES=0.28) and dyspnea (-7.6, -12.2; -3.0, ES=0.28). Two SAEs occurred (one wrist fracture and one sacral stress fracture), neither related to bone metastases. CONCLUSION: This large multinational study demonstrated significant beneficial effects of a supervised exercise intervention offered during palliative treatment on mBC patients’ fatigue, HRQoL, and other clinically relevant outcomes. Based on these findings, we recommend supervised resistance and aerobic exercise as part of supportive care regimens during palliative treatment of mBC. Citation Format: Anne May, Anouk Hiensch, Johanna Depenbusch, Martina Schmidt, Evelyn Monninkhof, Mireia Pelaez, Dorothea Clauss, Philipp Zimmer, Jon Belloso, Mark Trevaskis, Helene Rundqvist, Joachim Wiskemann, Jana Muller, Carlo Fremd, Renske Altena, Joanna Kufel-Grabowska, Rhode Bijlsma, Lobke van Leeuwen-Snoeks, Daan ten Bokkel-Huinink, Gabe Sonke, Bruce Mann, Prudence Francis, Gary Richardson, Isabel Álvarez, Wolfram Malter, Elsken Van der Wall, Neil Aaronson, Elżbieta Senkus, Ander Urriticoechea, Eva Zopf, Wilhelm Bloch, Martijn Stuiver, Yvonne Wengström, Karen Steindorf. Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-10.

Abstract PO3-28-01: More Than a Diagnosis: An Untold Story of Quality of Life

Abstract Background Advocates for Collaborative Education, a global coalition of patient, community, research, and policy advocates, initiated an anonymous, online survey to assess Quality of Life (QoL) impacts of cancer diagnosis and treatment to inform research, clinical care, and the broader cancer community. Identifying what matters most to individuals can potentially guide improvements in supportive care to effectively address QoL impacts. Methods A six-section, 93 question survey was co-created by patients, survivors, and advocates. Co-creation was instrumental in determining categories, specific questions, and measurement scales used to assess severity and impact of QoL challenges. Beyond demographic, treatment, and cancer diagnosis data, co-creation participants identified seventeen (17) treatment-related side effects. Survey questions asked about these side effects, their perceived severity, how well informed they felt about possibilities of experiencing these side effects, supportive care access, side effects of supportive care therapies, and personal preferences for receiving cancer-related information. Recruitment efforts for this online survey were conducted through advocacy groups and social media platforms. Results Across a wide range of demographic subsets, including age, race, stage of cancer, and treatment modalities, 334 respondents with a history of breast cancer reported a decline in QoL scores pre cancer vs post cancer according to the co-created measurement tool. Physical and emotional well-being emerged as top priorities for most respondents, 47.9% and 27.5% respectively. Of 17 listed side effects, respondents cited fatigue (49%), muscle/joint pain (36%), and emotional distress (35%) as primary concerns, with sexual dysfunction and cognitive impairment ranking prominently. Forty-six percent reported severe (frequent & highly disruptive) to very severe (constant & severely impacting quality of life) emotional distress, but only 55% of those felt informed or well informed about the possibility of emotional distress. Among respondents, only 41% received a plan to address emotional distress. Many felt unprepared for physical side effects as well. While 54% of individuals experienced diarrhea or fecal incontinence as a treatment side effect, 22% of affected individuals did not feel informed about the possibility of such side effects. Survey findings also highlight consequences of treatments to manage side effects. For example, 37% of respondents were prescribed treatment to address diarrhea and 100% of these patients reported additional side effects stemming from this supportive care including nausea, constipation, and fatigue. Detailed results for all categories as well as stratification by subsets of age, race, metastatic vs. early stage, treatment type, and others will be available for presentation and publication. Conclusion This study sheds light on an underexplored area of cancer research. Management of treatment side effects is integral to supportive care, yet supportive medications can introduce a cascade of their own side effects, exacerbating the overall burden on patients. Information and education are critical to bridge the gap. The collaboration with patients and survivors in developing this survey represents a pivotal step in determining areas that demand attention for improving QoL and offers valuable insights aimed at enhancing the well-being of individuals affected by cancer and additional research will pursue collaborative solutions. Demographic and High Level QoL Responses from MTAD (Breast) Detailed data on perceived severity, impact to QoL, perceived preparation for, and relevant supportive care is available for each side effect Citation Format: Stacey Tinianov, Kelly Shanahan, Catherine Thomsen, Ginny Mason, Laura Carfang, Joanne Mika Hayashi, Laurie Hutcheson. More Than a Diagnosis: An Untold Story of Quality of Life [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-28-01.

STRUCTURED EXERCISE IMPROVES FATIGUE AND HEALTH-RELATED QUALITY OF LIFE IN METASTATIC BREAST CANCER PATIENTS: THE MULTINATIONAL RANDOMIZED CONTROLLED PREFERABLE-EFFECT STUDY

INTRODUCTION & AIMS Exercise has been proven safe and effective for patients with breast cancer in the curative setting, however evidence in patients with metastatic breast cancer (mBC) is scarce. The aim of the PREFERABLE - EFFECT study (NCT04120298) was to evaluate the effects of a structured exercise program on fatigue, health-related quality of life (HRQoL), and other cancer- and treatment-related side effects in patients with mBC. METHODS The randomized controlled trial included patients with mBC from five European countries (Germany, Spain, Netherlands, Poland, Sweden) and Australia. Participants were randomly assigned to usual care (UC) or a 9-month supervised and individualized exercise program (EX) involving twice weekly aerobic, resistance, and balance exercises. The primary outcomes, physical fatigue (EORTC QLQ-FA12 subscale) and HRQoL (EORTC QLQ-C30 summary score) were assessed at baseline, 3, 6, and 9 months. Among other physical fitness outcomes, maximal short exercise capacity was assessed with the Steep Ramp Test. Changes from baseline to 3, 6 (primary endpoint) and 9 months were compared between groups using adjusted mixed models for repeated measures. RESULTS A total of 357 patients were randomized (EX=178, UC=179). On average, participants were 55.4 years of age (SD=11.1) and 73.9% had bone metastases. EX resulted in a significant reduction in physical fatigue (-5.3 [-10.0; -0.6], p=.027, ES=0.22) and improvement in HRQoL (+4.8 [2.2; 7.4], p=.0003, ES=0.33) compared to UC at 6 months (primary endpoint), as well as at 3 and 9 months. EX also improved physical fitness (+24.3 Watts, [15.5; 33.1], ES=0.42, at 6 months) and numerous relevant QLQ-C30 scales, including social functioning, pain, and dyspnoea. CONCLUSION This large multinational study demonstrates that supervised exercise improves fatigue, HRQoL, and other clinically relevant outcomes in patients with mBC. Based on these findings, supervised exercise should be recommended to patients with mBC.

In their voices: Kenyan women’s experiences with cancer treatment-related side effects

ObjectiveThis paper reports on a secondary analysis of a qualitative study conducted in Nairobi, Kenya which reported several initial themes. In this paper, the authors explore the theme of treatment-related side effect management by women receiving treatment for breast or cervical cancer. MethodsWomen were interviewed at three points during their active treatment trajectory. Participants were purposefully selected and saturation was reached when interviews did not yield any new themes. The interviews were transcribed and analyzed for internal consistency, frequency, extensiveness, intensity and specificity. The Nvivo pro 12 software was used in organizing and managing the data to facilitate analysis. ResultsEighteen women were interviewed. Major side effects reported by participants included fatigue, alopecia, skin and nail changes as well as nausea and vomiting. Women who received information prior to treatment were more comfortable managing side effects. Participants described the impact of side effects on their daily life, body image, and many sought comfort through faith. Some women provided suggestions on strategies for patient education. ConclusionsThis study attempted to capture the cancer treatment-related experiences of Kenyan women in their own voices and present strategies for future intervention and research. The care of individuals receiving treatment can be enhanced through the advancement of health human resources, the development of nationally accessible patient education materials and research on regionally relevant strategies to manage cancer treatment-related side effects.

Lymphoma of the central nervous system originating from the septum pellucidum region: Two case reports with literature review.

Central nervous system lymphoma (CNSL) originating from the septum pellucidum is exceptionally rare, presenting unique diagnostic and therapeutic complexities. This case report aims to elucidate the diagnostic challenges, treatment strategies, and outcomes of this rare manifestation. By documenting this case, we seek to enhance understanding within the medical community and contribute valuable insights to the management of CNSL, particularly in atypical locations. A 45-year-old female presented with persistent headaches, blurred vision, and motor weakness, prompting a thorough neurological evaluation. Imaging revealed an enhancing mass in the septum pellucidum, leading to the diagnosis of CNSL. The patient's concerns encompassed not only the physical symptoms but also the emotional impact of her diagnosis and treatment journey. Diagnostic confirmation of CNSL involved cerebrospinal fluid analysis and imaging findings, highlighting the challenge of distinguishing lymphoma from other intracranial pathologies. The case underscores the importance of comprehensive diagnostic evaluation in rare CNSL presentations. Multidisciplinary management included high-dose methotrexate-based chemotherapy and corticosteroids, with consideration for neurosurgical intervention. Psychosocial support and self-care strategies were integrated into the treatment plan to address holistic patient needs. Monitoring revealed a positive treatment response, with a reduction observed in the septum pellucidum mass. Regular assessments ensured adherence to interventions and management of treatment-related side effects, contributing to favorable outcomes and improved quality of life for the patient. This case emphasizes the significance of meticulous diagnostic evaluation and personalized treatment approaches in managing rare CNSL presentations. Collaboration among specialists and comprehensive patient support is paramount in optimizing outcomes and addressing the multifaceted challenges posed by CNSL in unique anatomical locations.

Cytotoxic activity and apoptosis induction by supernatant of Lentilactobacillus buchneri on HT-29 colon cancer cells

Background and Objectives: Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer and the third most deadly cancer in the world. According to recent experimental reports, probiotics and their derivatives protect CRC patients from treatment-related side effects. Therefore, the present study aimed to investigate the cytotoxic impact of the cell-free supernatant (CFS) of Lentilactobacillus buchneri on the HT-29 cancer cell line.
 Materials and Methods: In the current study, we used the L. buchneri CFS, which was well isolated and identified in our previous investigation from traditional yogurt in the Arak region of Iran. The apoptosis induction in HT-29 cancer cells was assessed by cell cytotoxicity, flow cytometry, and qRT-PCR.
 Results: L. buchneri CFS inhibited the proliferation of HT-29 cancer cells in a time- and dose-dependent manner. The apoptotic effect of CFS was further supported by the flow cytometry data, which showed that the maximum incidence of apoptosis 50 was observed in HT-29 cancer cells treated with the IC concentration of CFS after 72 hours. CFS of L. buchneri also exerted the up-regulating effect on the expression of pro-apoptotic genes including BAX, CASP9, and CASP3. L. buchneri CFS at an IC 50 dose induced cell cycle arrest in the G0/G1 phase in HT-29 cells.
 Conclusion: This study indicates that L. buchneri CFS can prevent colorectal cancer (CRC) development in patients by inducing cancer cell apoptosis. This finding suggests that the CFS of L. buchneri could be used as a therapeutic agent for the control of CRC.

"I couldn't carry on taking a drug like that": A qualitative study of patient perspectives on side effects from rheumatology drugs.

There is growing interest in collecting outcome information directly from patients in clinical trials. This study evaluates what patients with rheumatic and musculoskeletal diseases (RMDs) consider important to know about symptomatic side effects they may experience from a new prescription drug. Patients with inflammatory arthritis, who had one or more prescribed drugs for their disease for at least 12 months, participated in focus groups and individual interviews. Discussions were analysed using reflexive thematic analysis. We conducted seven focus groups with 34 participants across three continents. We found four overarching and two underpinning themes. The 'impact on life' was connected to participants 'daily life', 'family life', 'work life', and 'social life'. In 'psychological and physical aspects' participants described 'limitation to physical function', 'emotional dysregulation' and 'an overall mental state'. Extra tests, hospital visits and payment for medication were considered a 'time, energy and financial burden' of side effects. Participants explained important measurement issues to be 'severity', 'frequency', and 'duration'. Underpinning these issues, participants evaluated the 'benefit-harm-balance' which includes 'the cumulative burden' of having several side effects and the persistence of side effects over time. In treatment for RMDs, there seems to be an urgent need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit-harm-balance. These findings contribute new evidence in support of a target domain-an outcome that represents the patient voice evaluating the symptomatic treatment-related side effects for people with RMDs enrolled in clinical trials.

Factors influencing caregiver decisions to use complementary and integrative therapies in pediatric oncology settings: Findings from a qualitative analysis

PurposeComplementary and integrative medicine (CIM) therapies (i.e., non-conventional Western medicine interventions) may reduce side-effects associated with pediatric oncology treatment. CIM therapies may also improve caregiver psychological and physical health that is exacerbated during pediatric cancer treatment. Despite known benefits, these therapies are not widely used within pediatric oncology populations in the United States. To guide and promote CIM use among this population, the aim of this project was to qualitatively explore factors that contribute to caregivers' decision to include CIM use in their own and child's care. MethodsTwenty caregivers of children (ages 0.5–14 years) being treated for cancer participated in this study. Each completed a demographic form and the CIM use questionnaire. Qualitative interviews followed by a card sort task were used to assess barriers and facilitators of uptake for caregivers and their child with cancer. ResultsA number of predisposing (e.g., child age, beliefs) and needs factors (e.g., potential to treatment-related side-effects) provide insight into caregivers’ decisions to use CIM for their child. Analyses also revealed the importance of enabling factors (e.g., resources) for caregiver use. Caregivers also reported benefiting from additional information about risk/benefit analysis of these therapies, and current research for CIM use in caregivers and children being treated for cancer. ConclusionChildren may benefit from individually tailored complementary and integrative medicine consultations that explore patient history and specific needs factors to improve preference concordant care and uptake. Caregivers may benefit from support that improves enabling factors associated with care (e.g., improved accessibility).

Postoperative Pain Following Eye Enucleation: A Prospective Observational Study.

Background and Objectives: Enucleation of an eye is the most invasive procedure in ophthalmologic surgery. It can be the result of various diseases (malignant/chronic/trauma/infection) and is nevertheless relatively rare, but leads to the loss of a strongly innervated neuronal organ. This study systematically evaluates postoperative pain levels following enucleation of the eye globe. Materials and Methods: This prospective single-center study enrolled twenty-four patients undergoing enucleation of the eye globe. Perioperatively all patients completed (preoperative day, day of surgery, 1st, 2nd, and 3rd day following surgery) standardized questionnaires concerning their pain experience and treatment-related side-effects (internal protocol, QUIPS, painDETECT®). Patients received usual pain therapy in an unstandardized individual manner. Results: Preoperatively, mean average pain intensity of all included patients was 3.29 ± 2.46 (range, 0-8), 3.29 ± 3.24 (range, 0-8) on the day of surgery, 4.67 ± 1.90 (range, 2-10) on day 1, 3.25 ± 1.39 (range, 1-6) on day 2, and 2.71 ± 1.30 (range, 1-6) on day 3 after surgery. Mean maximum pain intensity was 4.71 ± 3.28 (range, 0-10) preoperatively, 4.04 ± 3.78 (range, 0-10) on the day of surgery, 5.75 ± 2.01 (range, 2-10) on day 1, 4.25 ± 1.89 (range, 2-10) on day 2, and 3.88 ± 1.54 (range, 2-8) on day 3 after surgery. Nineteen patients (79.2%) stated that they would have preferred more pain therapy. Conclusions: Patients undergoing eye enucleation report pain sensations in need of intervention in this university hospital. Thus, effective standardized pain treatment concepts are now a high priority to be established in an interdisciplinary manner containing standardized regimens and continuous regional procedures. Awareness of this problem in the medical team should be sharpened through targeted training and information.

The Development of a Multi-Modal Cancer Rehabilitation (Including Prehabilitation) Service in Sheffield, UK: Designing the Active Together Service.

Cancer patients undergoing major interventions face numerous challenges, including the adverse effects of cancer and the side effects of treatment. Cancer rehabilitation is vital in ensuring cancer patients have the support they need to maximise treatment outcomes and minimise treatment-related side effects and symptoms. The Active Together service is a multi-modal rehabilitation service designed to address critical support gaps for cancer patients. The service is located and provided in Sheffield, UK, an area with higher cancer incidence and mortality rates than the national average. The service aligns with local and regional cancer care objectives and aims to improve the clinical and quality-of-life outcomes of cancer patients by using lifestyle behaviour-change techniques to address their physical, nutritional, and psychological needs. This paper describes the design and initial implementation of the Active Together service, highlighting its potential to support and benefit cancer patients.

The Right Dose: Results of a Patient Advocate-Led Survey of Individuals With Metastatic Breast Cancer Regarding Treatment-Related Side Effects and Views About Dosage Assessment to Optimize Quality of Life.

Although patients with metastatic breast cancer (MBC) have been living longer with the advent of more effective treatments such as targeted therapy and immunotherapy, the disease remains incurable, and most patients will undergo therapy indefinitely. When beginning therapy, patients are typically prescribed dose often based upon the maximum tolerated dose identified in phase I clinical trials. However, patients' perspectives about tolerability and willingness to discuss individualized dosing of drugs upon initiation of a new regimen and throughout the course of treatment have not been comprehensively evaluated. Patient advocates and medical oncologists from the Patient-Centered Dosing Initiative (PCDI) developed a survey to ascertain the prevalence and severity of MBC patients' treatment-related side effects, the level of patient-physician communication, mitigation strategies, perception about the relative efficacy of higher versus lower doses, and willingness to discuss alternative dosing. The PCDI distributed the anonymous confidential online survey in August 2020 to individuals with self-reported MBC. One thousand and two hundred twenty-one patients with MBC completed the survey. 86.1% (n = 1,051) reported experiencing at least one significant treatment-related side effect, and of these, 20.3% (n = 213) visited the emergency room/hospital and 43.2% (n = 454) missed at least one treatment. Nearly all patients with side effects (97.6%, n = 1,026) informed their doctor and 81.7% (n = 838) received assistance. Of the 556 patients given a dose reduction for side-effect mitigation, 82.6% (n = 459) reported relief. Notably, majority of patients (53.3%, n = 651) do not believe that higher dose is always more effective than lower dose, and 92.3% (n = 1,127) would be willing to discuss flexible dosing options with their physicians based upon personal characteristics to optimize quality of life. Given that the majority of patients with MBC experienced at least one substantial treatment-related side effect and most patients given a dose reduction reported improvement, innovative dosage-related strategies are warranted to sustain and improve patients' well-being. Patient-physician discussions in which the patient's unique attributes and circumstances are assessed upon initiation of new treatment and throughout the course of therapy may facilitate the identification of the most favorable dose for each patient, and the majority of patients would be receptive to this approach.

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India.

Background Chemotherapy-induced nausea and vomiting is a common and unpleasant treatment-related side effect reported by cancer patients receiving chemotherapy. Akynzeo® or NEPA (NEtupitant + PAlonosetron) is the first fixed combination of netupitant and palonosetron that targets both critical pathways involved in emesis while providing a convenient, single oral dose therapy. The current study aimed to assess the effectiveness and safety of NEPA in a real-world setting in India. Methodology This was an open-label, multicenter, prospective, single-arm study conducted at six different locations across India. The study included patients of either gender, aged ≥18 years, naive to chemotherapy, scheduled to receive highly or moderately emetogenic chemotherapy (HEC/MEC), and scheduled to receive oral NEPA, as determined by the investigator. Results A total of 360 people were screened and enrolled in the study. HEC was prescribed to 289 (81.64%) patients, while MEC was prescribed to 65 (18.36%) patients. Complete response was achieved in 94.92% of patients during the acute phase, 95.20% during the delayed phase, and 93.22% during the overall phase. During the overall phase, 92.73% and 95.38% of patients on the HEC and MEC regimens, respectively, achieved complete response. Adverse events were reported in 3.88% of patients. Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases.

Efficacy and safety of the combination of oral tranexamic acid and intense pulsed light versus oral tranexamic acid alone in the treatment of refractory Riehl's melanosis: A prospective, comparative study.

There is no standardized and effective treatment modality for Riehl's melanosis. To compare the efficacy and safety of oral tranexamic acid (TXA) combined with intense pulsed light (IPL) versus TXA alone in the treatment of refractory Riehl's melanosis. A prospective study of 28 subjects with refractory Riehl's melanosis and Fitzpatrick Skin Types III or IV was conducted. All subjects received oral TXA 500 mg daily and 11 of them were treated in combination with monthly IPL therapy for 6 months. The primary outcome measure was mean melanin index (MI), erythema index (EI) and acquired dermal macular hyperpigmentation area and severity index (DPASI). The Physician Global Assessment (PGA) and patient satisfaction scale were documented. After treatment, DPASI, mean MI, and EI were significantly reduced in both groups. The group treated with combination therapy showed better improvement according to MI (p = 0.0032) and DPASI (p = 0.00468). PGA and patient satisfaction scale showed superior efficacy in the combination group. No significant difference was observed in treatment-related side effects. The combination of oral TXA and IPL proves to be a safe and satisfactory treatment strategy for refractory Riehl's melanosis.

Virtual Follow-Up in Patients Initiating Antineoplastic Treatment in the Ambulatory Setting.

Initiating antineoplastic therapy can be distressful and affect patient retention of treatment-related side effects and safety protocols. Return visits can range from 8 to 28 days after treatment, during which patients may develop treatment-related questions and toxicities. This study's objective is to evaluate how implementing a follow-up phone call 24-48 hours after initial antineoplastic infusion, compared with standard pretreatment education, affects patient satisfaction and education retention. We conducted a single-center pilot study where patients who were literate, English-speaking, with genitourinary malignancies, initiating intravenous chemotherapy or immunotherapy were eligible. The primary end point was patient knowledge retention. Secondary end points included patient satisfaction. The Leuven's Questionnaire Patient Knowledge Tool, a validated, standardized tool, was used to evaluate patient knowledge retention, with a higher score indicating more retention. Telephone follow-up was initiated 24-48 hours after initial infusion, where Leuven's Questionnaire was used to assess patient knowledge. A nurse then reinforced treatment-related education, reviewed notification parameters, and coordinated appropriate follow-up. One week later, participants were sent a follow-up Leuven's Questionnaire and standardized patient satisfaction assessment. Thirty-one patients with renal cell carcinoma, prostate, bladder, germ cell/testicular, or adrenal cancers were included in the study. Mean preintervention Leuven's Questionnaire score was 5.3 and mean postintervention score was 8.1 on a 1-10 scale (P < .0001). Ninety-seven percent of patients reported improved satisfaction postintervention. Proactive telephonic follow-up for oncology patients improves education retention, patient satisfaction, and has potential to improve patient safety and quality of care.

75 Inflammation and post-tx sickness syndrome as an explanation for late effects

The changing epidemiology of head and neck cancer, with an increase in HPV-positive oropharyngeal cancers and the refinement of a multidisciplinary approach, has led to an increase in the prevalence of long-term survivors after treatment. Consequently, a higher proportion of patients are suffering from late effects of the treatments, temporally defined as effects occurring or persisting more than 3 months after the end of the treatments. These late toxicities consist both of locoregional problems and systemic syndromes, with an impact on patients’ quality of life.There is still limited knowledge about the precise causes of these late toxicities, and at the same level, we lack predictive factors able to identify patients at higher risk of late effects. Treatment combinations with surgery followed by (chemo)radiation or with chemotherapy added to radiation with a radiosensitizing effect increase the probability of suffering from the late consequences of the same therapies. Pain, swallowing difficulties, trismus, osteonecrosis, dental disorders, mucositis, xerostomia or sticky saliva, hoarseness, lymphedema, and fibrosis are the most reported symptoms and signs, while fatigue, anxiety, depression, and cognitive impairment are the counterparts at the systemic level.There is growing evidence for the role of inflammation in the progression of cancer and treatment-related side effects. However, for head and neck cancer patients, there are still a lot of unanswered questions related to the role of inflammation as being both related to cancer disease and to the consequences of the intensive treatments carried out for this disease. In particular, it is well known that pro-inflammatory cytokines have been shown to be activated by malignant tumors and cancer treatment, and that their level during treatment is linked to higher acute toxicities. Also, the level of pro-inflammatory cytokines such as interleukin (IL)-1 beta (IL-1β), IL-6, IL-8, and tumor necrosis factor (TNF) has been correlated to higher mucositis, dysphagia, and pain due to the acute toxic effect of chemoradiation. However, researchers have not yet proven the association between the level of proinflammatory cytokines in the acute phase of the treatment and the development of late toxicities. Even the role of the same pro-inflammatory mediators in the follow-up period has a conflicting correlation with the late toxicities reported by the patients. Chronic inflammation may cause fibrosis, one of the key pathological features of radiation-induced late effects such as dysphagia and transforming growth factor beta (TGF-β) and TNF are involved in the formation of fibrosis in irradiated tissue. There is even more debate about the cause of systemic symptoms after cancer treatment. Head and neck cancer patients may develop the post-treatment sickness syndrome, consisting of chronic fatigue, mood alteration, cognitive impairment, and sleep problems, among the most frequently reported symptoms. The neuro-behavioral sickness model recapitulates all these symptoms as being related to the stress induced by the treatment, causing alterations in mood, cognition, nutritional intake, and the neurovegetative system. One of the hypotheses is that activation of peripheral pro-inflammatory cytokine networks transmits signals to the brain, which promote sickness behavior. The tissue damage induced by the oncological treatments would result in a self-perpetuating activation of biological processes, leading to a persistent inflammation condition that results in worsening systemic late effects over time. However, this theory needs to be carefully validated with prospective studies exploring patient-reported outcomes and their correlation with inflammatory mediators. According to this model, if inflammation recapitulates the locoregional and systemic late toxicities induced by the treatments, research should lead efforts to find ways to counteract it. From one side, it is possible to define de-escalating treatments that could offer the same level of cancer control with a reduced burden of acute and late toxicities. This is particularly awaited in HPV-positive cancer patients, who are usually younger patients, obtaining higher survival rates and thus a higher impact of toxicities on quality of life. On the other hand, it is important to define specific protocols to reduce the impact of inflammation in the long-term. In this regard, the role of physical exercise has been clearly underestimated, and recent research has shown benefits for the survival and quality of life of head and neck cancer patients. Also, even with less scientific evidence, nutrition could offer a less inflamed systemic status that could help minimize the late effects of cancer treatment. It is clear that research in this field is in its infancy, and we need to put more efforts into defining the translational correlates of late toxicities and exploring new ways to counteract the post-treatment sickness syndrome.