Treatment-induced Adverse Effects Research Articles

Subglottic hemangioma—prevalence, clinical presentation and treatment

This retrospective study aimed to investigate the clinical features and treatment of pediatric subglottic hemangioma (SH), identify risk factors for treatment-induced adverse effects, and identify a strategy for timely therapy discontinuation in children diagnosed with SH at the national pediatric center. Medical records of patients presented with stridor from 2010 to 2020 were retrieved and assessed, the diagnosis of SH was established via flexible bronchoscopy, and the patients were treated using propranolol with a subsequent gradual dose increase to 3 mg/kg body weight daily. A two-week oral steroids trial was added for those with circumferential lesions. Early indicators of a good therapeutic response included decreased stridor and primary lesion size on follow-up bronchoscopy performed one week after propranolol commencement. Duration of therapy, tailored individually based on bronchoscopy findings, and at least twelve months of treatment were the two main criteria for deciding therapy termination. Outpatient visits were arranged at least every three months. Our results showed that SH was the third most frequent cause of stridor (15/137 patients), and biphasic stridor was uniformly present as a typical symptom. Both clinical improvement and bronchoscopy findings confirmed the efficacy of the treatment. The mean therapy duration was 17 months. The only significant adverse event observed was hypoglycemic seizures in one infant. Contributory factors were all prematurity, high propranolol dose (3 mg/kg) and poor oral intake. Collectively, defining a safe and timely protocol for therapy cessation and avoidance of risk factors for adverse effects is the mainstay of SH treatment.

Therapeutic Modalities for Coronavirus SARS-CoV-2 (COVID-19)

The ongoing outbreak of coronavirus disease 2019 (COVID-19) that has accelerated in such short a period has spurred the investigation on existing and new therapeutic modalities. Therapeutic value of different classes of drugs have been tested including anti-parasites (Ivermectin), steroids (Dexamethasone), immune regulators (Tocilizumab), combination therapy MATH+ (Methylprednisolone, Ascorbic Acid, Thiamine), corticosteroid (Heparin), and antiviral medications (Molnupiravir or Paxlovid). Similarly, different types of vaccines, including mRNA-based vaccines, viral vector vaccines, and inactivated vaccines (requiring adjuvants) have also developed. Outbreaks of numerous COVID-19 variants, such as Omicron with rapid and frequent genomic mutations, have rendered vaccines less effectiveness against COVID-19. Due to short-term immune protection and treatment-induced adverse effects (e.g., vision problems, vertigo, diarrhea, nausea, allergic reaction, hypokalemia, hypertension, thrombosis with thrombocytopenia syndrome, Guillain-Bare syndrome, Bell’s palsy) boosters or secondary treatment is needed. Although various vaccines and therapeutics have been developed, further testing is required to obtain higher efficacy across age, gender, and race ranges and to establish long-term immunity. This review summarizes current treatment options available against COVID-19, their mechanisms of action, undesired side effects, as well as safety and efficacy protocols.

Abstract 3493: Comprehensive analysis of the DNA repair enzyme signature in tumor and blood cells from head and neck cancer patients and correlation with clinical data from a 18-months follow-up study

Abstract Head and neck squamous cell carcinoma (HNSCC) is the sixth leading cancer worldwide. It is often associated with a history of smoking/alcohol consumption or exposure to the human papilloma virus (HPV). Beyond surgery, treatment usually includes DNA damaging treatments i.e. cisplatin/5FU combined or not with radiation therapy. Treatment failure rates are still high due to intrinsic and acquired mechanisms of resistance, largely involving DNA repair mechanisms. Here we precisely examined the main DNA repair mechanisms susceptible to drive tumor progression and resistance to treatment, using a miniaturized comprehensive functional approach on biochip. Enzymatic DNA repair profiles were compared for lymphocytes and tumor biopsies taken before treatment from 38 patients in a prospective clinical study. We simultaneously investigated double strand break repair pathways (HR, NHEJ, SSA, alt-EJ), excision/synthesis repair mechanisms (BER, NER, ICLR) and several glycosylases/AP endonuclease activities, using lysates prepared from the samples. Results were correlated with physiologic and lifestyle/risk factors, TNM tumor classification, treatment-induced adverse effects, and disease progression or death at 18 months. Analysis of blood cells and biopsies provided different and complementary information. Indeed, the prediction of treatment-induced severe toxicity was effective on blood cells. Several risk factors significantly affected specific repair activities of tumor cells. HPV positive and negative tumors displayed distinct DNA repair profiles and, cancer progression and tumor staging correlated with deregulated repair activities in tumors. Interestingly, the most affected DNA repair activities concerned double strand break repair, repair of cisplatin adducts, and repair of oxidative damage. This accurate DNA repair profiling represents an innovative strategy to reveal tumor diversity and better understand the impact of risk factors. It improved our understanding of the role of DNA repair in the development and progression of cancer. In addition, the use of a panel of DNA repair-based enzymatic biomarkers is more accurate than the single parameter approach in stratifying patients into different groups, thus allowing for more effective therapeutic strategies. Citation Format: Sylvie Sauvaigo, Giovanna Muggiolu, Sarah Libert, Bertrand Treillard, Gersende Alphonse, Christian A. Righini, Philippe Ceruse, Pierre Philouze, Claire Rodriguez-Lafrasse. Comprehensive analysis of the DNA repair enzyme signature in tumor and blood cells from head and neck cancer patients and correlation with clinical data from a 18-months follow-up study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3493.

Gender and Sex-Related Differences in Normal Tissue Effects Induced by Platinum Compounds.

Gender medicine in the field of oncology is an under-researched area, despite the existing evidence towards gender-dependent response to therapy and treatment-induced adverse effects. Oncological treatment aims to fulfil its main goal of achieving high tumour control by also protecting normal tissue from acute or chronic damage. Chemotherapy is an important component of cancer treatment, with a large number of drugs being currently in clinical use. Cisplatin is one of the most commonly employed chemotherapeutic agents, used either as a sole drug or in combination with other agents. Cisplatin-induced toxicities are well documented, and they include nephrotoxicity, neurotoxicity, gastrointestinal toxicity, ototoxicity, just to name the most frequent ones. Some of these toxicities have short-term sequelae, while others are irreversible. Furthermore, research showed that there is a strong gender-dependent aspect of side effects caused by the administration of cisplatin. While evidence towards sex differences in animal models is substantial, clinical studies considering sex/gender as a variable factor are limited. This work summarises the current knowledge on sex/gender-related side effects induced by platinum compounds and highlights the gaps in research that require more attention to open new therapeutic possibilities and preventative measures to alleviate normal tissue toxicity and increase patients’ quality of life in both males and females.

Homoeopathic Treatment as an Add-On for Minimizing After Effects of Conventionally Treated Cancer Patients: A Simple Randomized Pilot Study—Protocol from Northeast India Perspective

The north-eastern region of India accounts for a total of 37,448 cancer cases reported from 11 population-based cancer registries (PBCRs) from 2012 to 2014. Studies suggest that with the holistic approach adopted by homoeopathy, not only the symptoms like cancer pain are alleviated, but also the overall well-being of the patient. Homoeopathy can be beneficial to minimize the treatment-induced adverse effects like radiation-induced mucositis, skin reactions, postoperative seroma, bleeding, and complications associated with the use of surgery, chemotherapy, and radiation therapy. This study intends to provide homoeopathic services as an add-on to conventional treatment to the patients referred for homoeopathic treatment after their due consent. The primary objective is to study the usefulness of homoeopathic medicines for combating the suffering of cancer patients having complaints other than cancer. A sample size of 70 patients per group in two arms (Arm A: standard allopathic drug and Arm B: standard allopathic drug + homoeopathic treatment) will be recruited using simple random sampling without repetition. Cancer patients reporting complaints other than cancer itself and suffering from the after-effects of cancer treatment with chemotherapy and radiation therapy to any reputed cancer institute will be screened and will be recruited according to inclusion and exclusion criteria. After completion of the six months study duration, results will be able to predict the role of homoeopathic treatment as an add-on to conventionally treated cancer patients to minimize the suffering other than cancer and the after-effects of chemotherapy and radiation therapy. If found significant, this could prove to be a contribution in the health care system in handling cancer cases that are very difficult to treat. Further, the cost-effectiveness of homoeopathy will enable developing countries to manage such a disease effectively.

Safety assessment of the standardized aqueous extract from solid-state cultured Xylaria nigripes (Wuling Shen) in rats

BackgroundXylaria nigripes (Koltz.) Cooke, also known as Wuling Shen, is a high-value medicinal mushroom. It is a herbal medicine traditionally used for treating insomnia, trauma and depression. However, its toxicity has never been systematically evaluated. This study aimed to evaluate the safety of a standardized aqueous extract (XNE), an ingredient of commercial products, prepared from solid-state cultured X. nigripes in rats.MethodsA 90-day subchronic toxicity study was conducted by oral administration of XNE at daily doses of 20, 1000 and 2000 mg/kg body weight to Sprague-Dawley rats of both sexes, and the control group was given distilled water (vehicle). All animals were checked daily for general behavior, body weight changes and signs of toxicity. At the end of the treatment period, hematological analysis, biochemical analysis and histopathological examination of organs were conducted.ResultsAt tested concentrations, oral XNE administration caused no treatment-induced adverse effects on general health, body weight gain, relative organ weights, and hematological and biochemical parameters. Histopathological results also showed no significant structural changes in organs even in high-dose XNE-treated animals.ConclusionThis study suggests that treatment with XNE for 90 days does not produce significant toxicity, even up to 100 fold (2000 mg/kg body weight/day) of the recommended daily intakes. Therefore, the use of XNE as herbal medicines is considered to be relatively safe.

Multi-Institutional Retrospective Analysis of the Outcomes of Proton Beam Therapy for Patients With 1 to 3 Pulmonary Oligometastases From Various Primary Cancers

PurposeOur purpose was to evaluate the efficacy of proton beam therapy (PBT) in patients with 1 to 3 pulmonary oligometastases from various primary cancers in Japan. Methods and MaterialsThis multi-institutional retrospective survey included 118 patients with 141 metastatic lung tumors from miscellaneous primary cancers, across 6 Japanese institutions, and involved the analyses of local progression-free rate (LPF), distant progression-free rate, progression-free survival rate, cause-specific survival rate, and overall survival rate (OS). Treatment-induced adverse effects of grade ≥2 were evaluated according to the Common Terminology Criteria for Adverse Events (version 4.0). Cox proportional hazards regression models were used in univariable analysis and multivariable analysis (MVA) for the identification of the prognostic factors of LPF and OS. ResultsThe median follow-up duration from the time of PBT was 25.5 months. The major primary disease sites included colorectal cancer (42.4%), lung cancer (11.9%), head and neck cancer (8.5%), and kidney cancer (8.5%). For years 1, 2, and 3, LPFs were 92.2%, 86.3%, and 78.4%; distant progression-free rates were 59.1%, 44.1%, and 34.0%; progression-free survival rates were 49.6%, 31.7%, and 24.2%; cause-specific survival rates were 83.4%, 72.5%, and 64.8%; and OS rates were 79.0%, 67.8%, and 59.6%, respectively. Eight patients developed acute adverse effects (grade ≥2). Ten patients developed radiation pneumonitis (grade 2) as a late adverse effect. None of the patients developed severe late toxicity (grade ≥3). Colorectal cancer as the primary disease was the only prognostic factor associated with LPF that remained independently significant in the MVAs performed using 3 sets of parameters (hazard ratio [HR], 3.31-4.76 in 3 MVA sets). In the MVA, the significant prognostic factors for OS were performance status (HR, 2.78; 95% confidence interval, 1.01-7.67) and total tumor volume (HR, 1.01; 95% confidence interval, 1.00-1.02). ConclusionsPBT provides promising outcomes for pulmonary oligometastasis with acceptable toxicities.

Reliability and Validity of the Greek Version of the Oral Mucositis Weekly Questionnaire in the Head and Neck Cancer Context.

Oral mucositis is one of the most common treatment-induced adverse side effects in head and neck cancer patients. The purpose was to evaluate the reliability and validity of the Greek version of the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). The data were retrieved from 72 head and neck cancer patients who were undergoing oral radiotherapy as monotherapy or in combination with chemotherapy and surgery. Data analyses included internal consistency reliability, criterion related validity, and cross-sectional validity. The OMWQ-HN demonstrated good criterion validity. Strong correlations were observed between OMWQ-HN with EORTC QLQ-C30 and EORTC QLQ-H&N35 that showed good concurrent validity. The tool has a strong internal consistency index with α = .92. The Greek version of OMWQ-HN is a reliable and valid instrument that can be used for the assessment of oral mucositis in this context.

Rationale and study protocol of the Physical Activity and Dietary intervention in women with OVArian cancer (PADOVA) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy

IntroductionAs a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising...

Covid-19 treatment-induced neuropsychiatric adverse effects

Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) was first notified in Wuhan, China, in December 2019, and has rapidly spread worldwide, due to its high transmission rate. It has been identified as the causative agent of the now termed coronavirus disease (COVID-19), which can range from mild condition to potentially fatal respiratory distress syndrome

Claims for compensation from women with cervical cancer in Norway-A retrospective, descriptive study of a 12-year period.

In Norway, all patient-reported claims for compensation are evaluated by The Norwegian System of Patient Injury Compensation (NPE). The number of claims from women with cervical cancer is rising, and the approval rate is high. Our aim was to study claims for compensation from women with cervical cancer to identify the type of failures, when, during the time-course of treatment, the medical failures occurred, and the consequences of the failures. A retrospective, descriptive study of claims for compensation to NPE from cervical cancer patients during a 12-year period, from 2007 through 2018. We used anonymized medical expert statements and summaries of NPE cases. In all, 161 women claimed compensation for alleged medical failure related to cervical cancer. Compensation was approved for 100 (62%) women. Mean age at the time of alleged failure was 37.5 years (SD ±9.9). The main reasons why women sought medical attention were routine cervical screening (56%), or vaginal bleeding or discharge (30%). In approved cases, incorrect evaluation of cytology and histology was the cause of most failures (72%). Mean delay of cervical cancer diagnosis for approved cases was 28 months (SD ±22). Treatment not in accordance with guidelines was the cause of failure in 2% of the cases, and failure during follow up was the cause of failure in 12%. Consequences of the failures were as follows: worsening of cancer prognosis (89%), treatment-induced adverse effects, such as loss of fertility (43%) and/or loss of ovarian function in premenopausal women (50%), and permanent injury after chemo-radiation (27%). Seven women (7%) died, most probably as a consequence of the failure. The main cause of medical failure in women with cervical cancer was incorrect pathological diagnosis. The main consequences of failures were worsening of cancer prognosis and treatment-induced adverse effects. Increased focus on the quality of pathological examinations, and better routines in all parts of the cervical examinations might improve patient safety for women in risk of cervical cancer.

Abstract B78: Co-potentiation of human T cells to identify subdominant tumor neoantigens from melanoma patients responding to immune checkpoint blockade

Abstract Malignant melanoma is the most aggressive form of skin cancer, accounting for 10,000 deaths annually. Largely resistant to conventional cytotoxic chemotherapy and radiation, immune checkpoint blockade (ICB) therapies have revolutionized patient care, accounting for partial or complete responses in up to 70% of patients. An important aspect of cancer elimination is activation of the cytotoxic T lymphocyte (CTL) response. Recent data suggest that ICB mediated broadening of the peripheral blood CTL repertoire correlates with good clinical outcomes. Thus, recent studies in cancer immunotherapy have focused on targeting tumor neoantigens (tNeoAg) with cancer vaccines for use in combination with ICB. Computational algorithm-driven predictions of immunogenic tNeoAgs yield vast numbers of potential peptide targets, only a fraction of which may be immunogenic in patients. This likely contributed to the modest success of cancer vaccines targeting predicted, high-avidity tNeoAgs, emphasizing the importance of identifying true tumor rejection antigens, including sub-dominant antigens, outside the scope of predictive models. In addition to promoting T cell-mediated tumor rejection, ICB often comes at the expense of treatment-induced immune-related adverse effects (irAE) that frequently require discontinuation of treatment. Modulation of ICB towards antitumor immunity and away from autoimmunity may dramatically improve the therapeutic index of modern cancer therapy. This appears feasible considering the clinical observation that antitumor efficacy does not correlate with type/severity of irAE, suggesting that the mechanisms of both processes, though likely related (CTL mediated), may not be identical. We aim to identify and separate non-cross-reacting antigenic targets mediating tumor rejection from those mediating irAEs to enable therapeutic interventions that maximize the efficacy of ICB, expanding tumor-specific CTLs with vaccines while minimizing irAEs through desensitization. We have access to samples from responding/nonresponding melanoma patients subjected to ICB with varying degrees of irAEs. We have designed an experimental approach that combines established mass spectrometry and sequencing techniques to identify peptides and matching TCR clones with a novel strategy that targets the TCR-associated CD3 complex to allow inclusion of subdominant antigens in our studies. T-cell “co-potentiation” is achieved when anti-CD3 monovalent Fabs induce a conformational change in the CD3 complex that sustains the T-cell response to weak antigenic stimulation. We have successfully used anti-human CD3 Fabs to co-potentiate in vitro the activation and subsequent response to weak peptide-HLA/TCR interactions of human T cells found in PBMCs isolated from healthy donors. Our preliminary data suggest T-cell co-potentiation may allow identification of ICB-induced CTL clones specific for subdominant tNeoAgs and irAE targets in patients with melanoma undergoing active immunotherapy. Citation Format: Laura Elsbernd, Alfreda Nelson, Hien Huynh, Michele Hoffmann, Christopher Parks, Wendy Nevala, Shari Sutor, Larry Pease, Adam Schrum, Diana Gil, Svetomir N. Markovic. Co-potentiation of human T cells to identify subdominant tumor neoantigens from melanoma patients responding to immune checkpoint blockade [abstract]. In: Proceedings of the AACR Special Conference on Tumor Immunology and Immunotherapy; 2018 Nov 27-30; Miami Beach, FL. Philadelphia (PA): AACR; Cancer Immunol Res 2020;8(4 Suppl):Abstract nr B78.

Heavy Resistance Training in Breast Cancer Patients Undergoing Adjuvant Therapy.

Adjuvant breast cancer therapy may reduce maximal muscle strength, muscle mass, and functional performance. Although maximal strength training (MST) has the potential to counteract this debilitating outcome and is shown to be superior to low- and moderate-intensity strength training, it is unknown if it can elicit effective adaptations in patients suffering treatment-induced adverse side effects. Fifty-five newly diagnosed stage I to III breast cancer patients (49 ± 7 yr) scheduled for adjuvant therapy were randomized to MST or a control group. The MST group performed 4 × 4 repetitions of dynamic leg press at approximately 90% of one-repetition maximum (1RM) twice a week for 12 wk. In the MST group, improvements in 1RM (20% ± 8%; P < 0.001) were accompanied by improved walking economy (9% ± 8%) and increased time to exhaustion during incremental walking (9% ± 8%; both P < 0.01). Moreover, the MST group increased 6-min walking distance (6MWD; 10% ± 7%), and chair rising (30% ± 20%) and stair climbing performance (12% ± 7%; all P < 0.001). All MST-induced improvements were different from the control group (P < 0.01) which reduced their 1RM (9% ± 5%), walking economy (4% ± 4%), time to exhaustion (10% ± 8%), 6MWD (5% ± 5%), chair rising performance (12% ± 12%), and stair climbing performance (6% ± 8%; all P < 0.01). Finally, although MST maintained estimated quadriceps femoris muscle mass, a decrease was observed in the control group (7% ± 10%; P < 0.001). The change in 1RM correlated with the change in walking economy (r = 0.754), time to exhaustion (r = 0.793), 6MWD (r = 0.807), chair rising performance (r = 0.808), and stair climbing performance (r = 0.754; all P < 0.001). Lower-extremity MST effectively increases lower-extremity maximal muscle strength in breast cancer patients undergoing adjuvant therapy and results in improved work economy, functional performance, and maintenance of muscle mass. These results advocate that MST should be considered in breast cancer treatment.

Breast Cancer during Pregnancy-Current Paradigms, Paths to Explore.

Breast cancer is the most common form of malignancy in pregnant women. The prevalence of pregnancy-associated breast cancer (PABC) is up to 0.04% of pregnancies and is expected to rise in developed countries. PABC represents a unique clinical scenario which requires a delicate balance of risks and benefits for both maternal and fetal well-being. Currently, there is paucity of data regarding the short- and long-term outcomes of in-utero exposure to anti-neoplastic agents. In general, when possible, treatment for PABC should follow the same guidelines as in non-pregnant patients. Surgery, including sentinel lymph node biopsy, is possible during all trimesters of pregnancy. Radiotherapy is contraindicated during pregnancy, although it might be considered in highly selected patients based on risk–benefit assessment. Evidence supports that administration of chemotherapy may be safe during the second and third trimesters, with cessation of treatment three weeks prior to expected delivery. Currently, hormonal therapy and anti-HER2 agents are contraindicated during pregnancy and should be postponed until after delivery. Prematurity is associated with worse neonatal and long-term outcomes, and thus should be avoided. While current data on the long-term effects of anti-neoplastic treatments are reassuring, grade of evidence is lacking, hence additional large prospective studies with long-term follow-up are essential to rule out any treatment-induced adverse effects.

New treatment-induced adverse effects we need to learn as modern hepatologists.

New treatment-induced adverse effects we need to learn as modern hepatologists.

Salvage Carbon-Ion Radiation Therapy For Locoregionally Recurrent Head and Neck Malignancies

To investigate the safety and efficacy of salvage carbon-ion radiation therapy (CIRT) in patients with locoregionally recurrent head and neck malignancies. One hundred and forty-one patients with locally recurrent head and neck malignancies previously treated with radiotherapy were salvaged using intensity-modulated carbon-ion radiation therapy (CIRT). The median dose was 60 Gray-Equivalent (GyE) (range 50–69 GyE, 2.0~3.5 GyE/daily fraction). All patients completed planned CIRT except for one. With a median follow-up time of 14.7 (range 1.6–36.4) months, the 1-year overall survival rate was 95.9%. Local, regional, and distant progression free survival rates were 84.9% and 97.7%, and 96%, respectively. Grade 3 or higher acute and late toxicities were observed in 7.1% of the patients. Ten patients developed mucosal necrosis and 4 of these patients deceased. Due to its physical and biological characteristics, CIRT appeared to be an acceptable treatment option for patients with locoregionally recurrent head and neck malignancies after previous radiotherapy. Treatment-induced adverse effects and early response to CIRT were both favorable. Longer follow-up is needed to evaluate the long-term outcome in terms of disease control, survival, as well as potential late effects.

Physical activity and associations with treatment-induced adverse effects among prostate cancer patients.

The present study aimed to determine the level of physical activity (PA) among prostate cancer (PCa) patients across treatment modalities and explore the association between PA and treatment-induced adverse effects (AEs). The present study was based on a cross-sectional postal survey among members of the Norwegian Prostate Cancer Association. Patients were eligible for the present study if they had either (1) completed radical prostatectomy, (2) completed radiotherapy and (neo)-adjuvant androgen deprivation therapy (ADT), or (3) were undergoing lifelong ADT. Adverse effects were measured by the Expanded Prostate Cancer Index Composite for Clinical Practice. In total, 696 patients were included. There was no statistically significant difference in level of PA across treatment modalities. Bowel symptoms mainly related to radiotherapy decreased the odds of exercising ≥ 2 times per week, along with age ≥ 70years, participation in the workforce, and BMI ≥ 25kg/m2. Among patients who were undergoing ADT, 5years or more since diagnosis reduced the odds of exercising ≥ 2 times per week by almost 60%. The level of PA did not differ across PCa patients treated with different modalities. Increasing bowel symptoms reduced the likelihood of exercising ≥ 2 times per week. PCa patients should be educated about possible treatment-induced AEs affecting PA level, enabling them to counteract the development of physical inactivity.

Ultrasound-guided microfoam sclerotherapy with polidocanol for symptomatic giant hepatic cyst: Initial experience.

In cases of symptomatic giant hepatic cysts, appropriate treatment is required to relieve symptoms. Ethanol, minocycline hydrochloride, and ethanolamine oleate have been conventionally used for ultrasound (US)-guided sclerotherapy. However, liquid sclerosing agents could mix with the residual fluid in the cyst and reduce their sclerotic effects. We carried out US-guided microfoam sclerotherapy using polidocanol for three patients and evaluated its efficacy and safety. Between May 2016 and March 2017, three female patients with symptomatic giant hepatic cysts were referred to our hospital. All of them were prospectively included in this study. The maximum diameters of the hepatic cysts in the three patients were 92 × 89 × 86mm, 155 × 119 × 140mm, and 223 × 195 × 123mm, respectively. Polidocanol microfoam was successfully administered through an 8.5-Fr pigtail catheter for all patients. One, two, and three microfoam sclerotherapy sessions were undertaken according to the initial cyst volume for cases 1, 2, and 3, respectively. The mean reduction rates of the cyst volume were 90.1% (85.5-98.9%) at 3months, 96.3% (91.9-99.9%) at 6months, and 99.5% (99.1-99.9%) at 9months after treatment. No significant treatment-induced adverse effects were observed. Ultrasound-guided microfoam sclerotherapy using polidocanol could be an effective and safe method for the treatment of symptomatic giant liver cysts.

Efficacy of a multi-component exercise programme and nutritional supplementation on musculoskeletal health in men treated with androgen deprivation therapy for prostate cancer (IMPACT): study protocol of a randomised controlled trial

BackgroundProstate cancer is the most commonly diagnosed cancer in men in developed countries. Androgen deprivation therapy (ADT) is a systemic treatment shown to increase survival in selected patients with prostate cancer. The use of ADT continues to increase for all stages and grades of prostate cancer despite known treatment-induced adverse effects. The primary aim of this study is to examine the efficacy of a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement on bone health in men treated with ADT for prostate cancer. Secondary aims are to determine the effects of this intervention on measures of total body and regional body composition, cardiometabolic risk, inflammatory markers, health-related quality of life and cognitive function.MethodsThis study is a two-arm randomised controlled trial. Men currently treated with ADT for prostate cancer will be randomised to either a 52-week, community-based, exercise training and nutritional supplementation intervention (n = 51) or usual care control (n = 51). Participants will be assessed at baseline, 26 weeks and 52 weeks for all measures. The primary outcome measures are proximal femur and lumbar spine areal bone mineral density (BMD). Secondary outcomes comprise: changes in tibial and radial bone structure and strength, total body and regional body composition, muscle strength and function, as well as cardiometabolic health, catabolic/inflammatory and anabolic/anti-inflammatory cytokines, health-related quality of life and cognitive function.DiscussionThis study investigates whether a multi-component intervention incorporating a targeted bone and muscle-loading programme in combination with a protein-, calcium- and vitamin D-enriched supplement can ameliorate multiple adverse effects of ADT when compared to usual care. The results will contribute to the development of exercise training and nutrition guidelines for optimising overall health in men treated with ADT for prostate cancer.Trial registrationAustralia New Zealand Clinical Trial Registry (ANZCTR), ID: ACTRN12614000317695. Registered on 25 march 2014.

Cognitive decline in prostate cancer patients undergoing ADT: a potential role for exercise training.

Androgen deprivation therapy (ADT) is an effective and widely prescribed treatment for prostate cancer (PCa), but it is associated with multiple treatment-induced adverse effects that impact on various musculoskeletal and cardiometabolic health outcomes. Emerging research has shown that ADT is also associated with cognitive impairment, which has been linked to a loss of independence, increased falls and fracture risk and greater use of medical services. The aim of this review is to outline the evidence related to the effect of ADT use on cognitive function, and propose a role for exercise training as part of usual care to prevent and/or manage cognitive impairments for PCa survivors on ADT. The following results have been obtained from this study. ADT has been shown to adversely affect specific cognitive domains, particularly verbal memory, visuomotor function, attention and executive function. However, current clinical guidelines do not recommend routine assessment of cognitive function in these men. No studies have examined whether exercise training can preserve or improve cognitive function in these men, but in healthy adults', multimodal exercise training incorporating aerobic training, progressive resistance training (PRT) and challenging motor control exercises have the potential to attenuate cognitive decline. In conclusion, as treatment with ADT for men with PCa has been associated with a decline in cognition, it is recommended that cognitive function be routinely monitored in these men and that regular exercise training be prescribed to preserve (or improve) cognitive function. Assessment of cognition and individualised exercise training should be considered in the usual treatment plan of PCa patients receiving ADT.