Functional Assessment Of Cancer Therapy-Fatigue Research Articles

Neurocognitive Dysfunction and predictors in non-CNS cancer patients: Rationale and methods for the neuro-oncology research at a South African academic hospital

BackgroundThe focus on central nervous system (CNS) malignancies has overshadowed scant but substantial research that suggests non-central nervous cancer patients experience cancer-related cognitive impairment (CRCI), which affects higher-order brain function and influences their quality of life. Despite such evidence of the occurrence of CRCI among non-CNS cancer patients, the factors associated with the CRCIs remain a highly debated issue with discrepancies noted. Whether non-CNS cancer itself can affect the brain independent of cancer treatment is an important question to unpack. This necessitates further research, particularly in the sub-Saharan region where the evidence is limited. MethodsThis study aims to assess the effect of chemotherapy-associated cognitive and affective changes in non-CNS cancer patients. A non-experimental, time-series, correlational design will be used, in which a battery of computerized neuropsychological tests will be administered, including the e-MoCA, the CNS Vital Signs, the Patient Health Questionnaire-4, the Center for Epidemiologic Studies Depression Scale, the Hamilton Anxiety Rating Scale, the Functional Assessment of Cancer Therapy-Fatigue, and the Semi-structured Interview Schedule. Descriptive and inferential statistical analysis will be conducted, as well as NVivo thematic analysis of the qualitative data. The scope of the neurocognitive issues and risk factors that may be present in cancer patients and survivors in a developing environment could be determined by this study. ImplicationsThe study is expected to extend research on the extent at which cancer and cancer treatments are associated with neurocognitive changes among non-CNS cancer patients and their impact on their quality of life in the local context. The results are expected to inform treatment providers to develop treatment guidelines tailored for individuals diagnosed with cancer and who have received cancer treatment, as well as individualized psychosocial interventions aimed at addressing psychological challenges associated with quality of life among cancer survivors.

Home-based versus supervised group exercise in men with prostate cancer on androgen deprivation therapy: A randomized controlled trial and economic analysis

IntroductionDifferences between health outcomes, participation/adoption, and cost-effectiveness of home-based (HOME) interventions and supervised group-based training (GROUP) in men with prostate cancer (PC) on androgen deprivation therapy (ADT) are currently unknown. The objective of this study was to assess the clinical efficacy, adherence, and cost-effectiveness of HOME versus GROUP in men on ADT for PC. Materials and MethodsThis was a multicentre, 2-arm non-inferiority randomized controlled trial and companion cost-effectiveness analysis. Men with PC on ADT were recruited from August 2016 to March 2020 from four Canadian centres and randomized 1:1 to GROUP or HOME. All study participants engaged in aerobic and resistance training four to five days weekly for six months. Fatigue [Functional Assessment of Cancer Therapy-Fatigue (FACT-F)] and functional endurance [6-min walk test (6MWT)] at six months were the co-primary outcomes. Secondary outcomes included quality of life, physical fitness, body composition, blood markers, sedentary behaviour, and adherence. Between-group differences in primary outcomes were compared to margins of 3 points for FACT-F and 40 m for 6MWT using a Bayesian analysis of covariance (ANCOVA). Secondary outcomes were compared with ANCOVA, Costs included Ministry of Health costs, program costs, patient out-of-pocket, and time costs. Trial Registration: #NCT02834416. ResultsThirty-eight participants (mean [standard deviation (SD)] age, 70 [9.0] years) were enrolled (GROUP n = 20; HOME n = 18). There was an 89.8% probability that HOME was non-inferior to GROUP for both fatigue and functional endurance and a 9.5% probability that HOME reduced fatigue compared to GROUP (mean [SD] change, 12.1 [8.1] vs 3.6 [6.1]; p = 0.040) at six months. Adherence was similar among study arms. HOME was cost-saving (mean difference: -$4122) relative to GROUP. DiscussionA HOME exercise intervention appears non-inferior to GROUP for fatigue and functional endurance and requires fewer resources to implement. HOME appears to ameliorate fatigue more than GROUP, but has comparable effects on other clinically relevant outcomes. Although limited by sample size and attrition, these results support further assessment of home-based programs.

Effects of Pilates method on quality of life, fatigue and sleep quality among breast cancer women receiving hormone therapy – Two-arm randomized clinical trial

ObjectiveTo analyze the effect of the Pilates method on the quality of life, fatigue, and sleep quality of patients undergoing adjuvant clinical treatment with hormone therapy for breast cancer. MethodsA randomized two-arm clinical trial with 34 breast cancer women that were randomized into two groups: a) Intervention group, who performed 16 weeks of mat Pilates; b) Control group, who maintained their daily routine activities and received three educational sessions. The questionnaires for each variable were applied before the intervention, after the intervention, and six months after the end of the intervention. Quality of life was assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), fatigue by the Functional Assessment of Cancer Therapy-Fatigue (FACT-F), and sleep quality by the Pittsburgh Sleep Quality Index. ResultsThe fatigue variable presented a time effect (p = 0.034) regardless of the analyzed group, in which a difference was found between baseline and the post-intervention period (p = 0.037). The variable sleep showed an effect of time (p = 0.025), presenting a difference between the baseline period and six months, with improvement for all participants (p = 0.004). Global health also showed a positive change also for all participants, with an isolated effect of time (p = 0.024). ConclusionInterventions based on the Pilates method may bring positive results in quality of life, fatigue, and sleep quality in patients undergoing adjuvant treatment for breast cancer, but further studies on the subject are needed to prove the results in a larger number of patients.

Effect of Multimodal Intervention on Cancer-Related Fatigue and Quality of Life among Patients Undergoing Cancer Treatment—Pilot Study (Part 1)

Abstract Background Cancer-related fatigue (CRF) is the most common and devastating problem in cancer patients even after successful treatment. CRF has a severe impact on daily activities, social relationships, reintegration, and overall quality of life (QOL). Objective This study was done to evaluate the effect of multimodal intervention (MMI) on CRF and QOL among cancer patients undergoing cancer treatment. Materials and Methods One group before-and-after study (pre-experimental design) was conducted among cancer patients undergoing cancer treatment who met inclusion criteria and were selected using a purposive sampling technique, in selected hospitals. MMI consisted of exercise program, acupressure, and home care management guide. Pre-test CRF and QOL were assessed on first day using a FACIT-F scale (Functional Assessment of Chronic Illness Therapy: Fatigue) and Functional Assessment of Cancer Therapy: Fatigue (FACT-G) Version 4, respectively. Post- test for CRF was further determined after 7 days, 21 days, and 3months and QOL was determined after 21 days and 3 months. Statistical Analysis Demographic and clinical characteristics of the participants are presented as frequency and percentage. Comparison of pre- test and post-test means of CRF and QOL is done by repeated measures analysis of variance (ANOVA). Correlation between fatigue and QOL of cancer patients was found by using Pearson correlation test. Results The mean pre-test fatigue score of the cancer patients (pre-test mean= 25.21) was lower than their mean post-test fatigue scores (post-test 1 =25.83, post-test 2 = 28.28, and post-test 3 = 34.72). There was a significant difference in CRF and QOL scores between before and after the MMI. In the repeated measures ANOVA, p-value is less than 0.05 (level of significance p < 0.05). Conclusion Regardless of mechanism of occurrence of fatigue, most patients living with cancer suffer with persistent CRF. Yet it is often not assessed, has limited treatment options, there is a need to assess the state of fatigue in cancer patients. They do need intervention to reduce the fatigue and to improve the QOL. Nonpharmacological therapies are the best strategies to manage the fatigue among cancer patients without any safety issue.

Electroacupuncture for treating cancer-related insomnia: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial

BackgroundInsomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.MethodsPeople with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.ResultsTwenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks’ follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.ConclusionsElectroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registrationClinical Research Information Service, KCT0002162. Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016),

Review and Assessment of Patient-Reported Outcomes (PRO) in Patients with Chemotherapy-Induced Anemia (CIA)

OBJECTIVES: Chemotherapy-induced anemia (CIA) is a common adverse event of cancer treatment and is associated with several symptoms that negatively impact health-related quality of life (HRQoL). Due to the nature of CIA signs and symptoms, the use of fit-for-purpose PRO measures reflecting patients' experience of the disease and its treatment is an important step in drug development and evaluation. In this project, we aimed to review and assess the most commonly used PRO measures to best capture the experiences of patients with non-myeloid malignancies.METHODS: A targeted literature review (TLR), including searches of the OVID database, US FDA/European Medicines Agency (EMA), clinical trial databases, regulatory labelling data and health technology assessment (HTA) reports/payer landscape recommendations, was conducted to identify PRO measures used to capture symptoms and HRQoL outcomes in non-myeloid cancer patients with CIA (2008-2021). PRO measures were identified from published studies, phase 2-4 clinical trials, and categorized according to the concept(s) measured and cancer type. Study outcomes were used to determine the optimal PRO strategy to capture the CIA symptoms of patients with non-myeloid cancer. The concepts captured from PROs identified in the TLR were used to develop a preliminary ‘conceptual model’: a graphical representation of signs and symptoms, and the perceived impact on HRQoL.Selected PRO measures, most relevant to the study objectives, were evaluated for their reliability, validity, responsiveness, and extent to which they cover HRQoL domains of interest and, in relation to the current regulatory environment, industry standards and guidance (e.g., FDA Guidance For Industry: Patient-Reported Outcome Measures, 2009). Reviews of the HTA guidelines and reports were conducted to provide insights into the applicability of PRO data from an HTA perspective.RESULTS: The conceptual model captured fatigue as the most important disease-related symptom experienced by non-myeloid cancer patients with CIA (Figure). The OVID search identified 17 PRO measures, which were then categorized by the key CIA-related concepts they assessed, including: sleep quality; HRQoL; anemia-related symptoms; depression/anxiety; and work productivity/activity impairment. The most frequently used PRO was the Functional Assessment of Cancer Therapy-Fatigue (FACT-F, N=11), followed by the FACT-Anemia (FACT-An, N=6). Ten PRO measures were identified from Phase 2-4 ongoing/completed US clinical trials and 6 PROs from EU clinical trials, with FACT-F (N=13) being the most common instrument used . FDA and EMA HRQoL-related product labelling information included the FACT-An, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Cancer Linear Analogue Scale (CLAS).From the TLR results, 9 PRO measures were selected for further review: FACT-An (An, Anemia); FACT-F; FACT-G (G, General); Functional Assessment of Chronic Illness Therapy-F; Patient-reported Outcomes Measurement Information System-F; Brief Fatigue Inventory; Visual Analogue Scale-F; Fatigue Symptom Inventory; and EORTC QLQ-C30. Of these, FACT-An was the only PRO measure specifically developed to measure fatigue and HRQoL in anemic cancer patients. FACT-An includes four HRQoL domains (assessing physical, social/family, emotional and functional wellbeing) from the FACT-G, plus an anemia subscale that comprises a fatigue subscale (13 items) and 7 anemia-specific questions.Results from the HTA/payer landscape review also indicated that the majority of recent HTA submissions reported findings from EORTC QLQ-C30 alongside the EORTC disease-specific adaptations for oncology-related indications and the EQ-5D. Many of the recent HTAs reported data from 2 or more different PRO measures.CONCLUSIONS: CIA impacts various aspects of patients' HRQoL; however, current PRO measures may only partially capture concepts of interest to patients. Multiple measures may be needed to adequately reflect all domains affected by CIA. Future studies may consider conducting concept elicitation interviews with patients and clinicians, to inform future updates to the conceptual model, and validation work to estimate meaningful change thresholds for these measures if not available. [Display omitted] DisclosuresMorga: Astellas Pharma Europe Ltd.: Current Employment. Atzinger: Astellas Pharma Inc.: Current Employment. Barsdorf: Clinical Outcomes Solutions: Current Employment. New: IQVIA: Current Employment. Alexandre: Astellas Pharma Europe B.V.: Current Employment.

Absence of risk of sarcopenia protects cancer patients from fatigue.

Cancer and its treatments often lead to sarcopenia and fatigue. However, whether these factors are associated remains unproven. To evaluate whether the risk of sarcopenia predicts the presence of fatigue. A cross-sectional study was completed and included 198 cancer patients of both sexes, undergoing in- and outpatient treatment. The Strength, Assistance for walking, Rise from a chair, Climb stairs, and Falls (SARC-F) and the Functional Assessment of Cancer Therapy Fatigue (FACT-F) were used to assess the risk of sarcopenia and the presence of fatigue, respectively. The cut-off values used to identify the risk of sarcopenia and the severity of fatigue scale were SARC-F ≥ 4 and Fatigue <34, respectively. Logistic regression analysis was performed to evaluate the association between SARC-F and the FACT-F. Out of 198 patients, 35% were at risk of sarcopenia and of these 87% had fatigue. Patients at risk of sarcopenia had lower scores in the FACT-F subscales, lower handgrip strength, lower performance status, were mostly hospitalized and were sedentary. Logistic regression analysis revealed that patients with SARC-F < 4 had a lower risk of fatigue in both models, crude (OR: 0.83; CI 95% [0.79-0.88], p < 0.0001) as well as adjusted for age, gender, BMI, physical activity, current use of alcoholic beverages, smoking, performance status, cancer type, clinical setting and use of supplements (OR: 0.87; CI 95% [0.81-0.92], p < 0.0001). In patients with cancer, 35% presented risk of sarcopenia and of these 87% had fatigue. In addition, the absence of sarcopenia was considered protective against fatigue.

Fatigue, anxiety, depression and sleep quality in patients undergoing haemodialysis

ObjectivePatients undergoing haemodialysis may experience troubling symptoms such as fatigue, anxiety, depression and sleep quality, which may affect their quality of life. The main objective of this study is to determine the prevalence of fatigue, anxiety, depression and sleep quality among patients receiving haemodialysis during the coronavirus disease 2019 (COVID-19) pandemic, and to explore the contributing predictors.MethodsA cross-sectional and descriptive correlational design using Qualtrics software was performed. Data were collected using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F), the Hospital Anxiety and Depression Scale (HADS) and the Pittsburgh Sleep Quality Index (PSQI). Logistic regression analyses were used to explore the predictors that were associated with fatigue, anxiety, depression and sleep quality.ResultsOf the 123 patients undergoing haemodialysis who participated, 53.7% (n = 66) reported fatigue, 43.9% (n = 54) reported anxiety, 33.3% (n = 41) reported depression and 56.9% (n = 70) reported poor sleep. Fatigue, anxiety and sleep quality (P < .05) were significantly associated with being female, and whether family members or relatives were suspected or confirmed with COVID-19. Logistic regression showed that being within the age group 31–40, having a secondary education level, anxiety, depression and sleep quality were the main predictors affecting the fatigue group.ConclusionFatigue, anxiety, depression and sleep quality are significant problems for patients receiving haemodialysis during the COVID-19 pandemic. Appropriate interventions to monitor and reduce fatigue, psychological problems and sleep quality amongst these patients are needed. This can help to strengthen preparations for responding to possible future outbreaks or pandemics of infectious diseases for patients receiving haemodialysis.

Sharing and caring: The impact of social support on quality of life and health outcomes in hematopoietic stem cell transplantation.

Social support is crucial for successful recovery after hematopoietic stem cell transplantation (HSCT) and has the potential to affect patient quality of life (QOL) and health outcomes. However, there are limited data on the relationship between a patient's perception of his or her social support and these outcomes. The authors conducted a secondary analysis of 250 autologous and allogeneic HSCT recipients enrolled in 2 supportive care trials at Massachusetts General Hospital from April 2011 through February 2016. They assessed social support as a patient's perception of his or her social well-being via the social well-being subscale of the Functional Assessment of Cancer Therapy. The authors used multivariate regression analyses to examine the relationship between pretransplant social well-being and QOL (Functional Assessment of Cancer Therapy-Treatment Outcome Index), psychological distress (Hospital Anxiety and Depression Scale), posttraumatic stress disorder [PTSD] symptoms (PTSD Checklist), fatigue (Functional Assessment of Cancer Therapy-Fatigue), and health care utilization (hospitalizations and days alive and out of the hospital) 6 months after HSCT. Participants were on average 56.4 years old (SD, 13.3 years); 44% (n = 110) and 56% (n = 140) received autologous and allogeneic HSCT, respectively. Greater pre-HSCT social well-being was associated with higher QOL (B = 0.10; 95% CI, 0.06-0.13; P < .001), lower psychological distress (B = -0.21; 95% CI, -0.29 to -0.12; P < .001), and lower PTSD symptoms (B = -0.12; 95% CI, -0.19 to -0.06; P < .001). Pre-HSCT social well-being was not significantly associated with fatigue or health care utilization 6 months after HSCT. Patients with higher pre-HSCT perceptions of their social support reported better QOL and lower psychological distress 6 months after HSCT. These findings underscore the potential for social support as a modifiable target for future supportive care interventions to improve the QOL and care of HSCT recipients.

Qualidade de vida de mulheres submetidas à mastectomia e à cirurgia conservadora

OBJETIVO: Descrever a percepção que as mulheres mastectomizadas e àquelas submetidas à cirurgia conservadora têm sobre sua qualidade de vida.MÉTODOS: Estudo descritivo que adotou o instrumento Functional Assessment of Cancer Therapy-Fatigue (FACT-F) para investigar a qualidade de vida de 20 mulheres com câncer de mama submetidas à intervenção cirúrgica. Os resultados foram apresentados por meio de estatística descritiva. Na análise dos resultados, foram comparados os resultados encontrados e as informações presentes na literatura científica.RESULTADOS: A média de idade entre as mulheres mastectomizadas foi de 52±10 anos e, das submetidas a cirurgia conservadora, de 50±8 anos. A maior parte era do lar ou aposentada (60%), casada (75%) e com um ou dois filhos (65%). Predominou entre as participantes a escolaridade de ensino médio (35%). Os valores médios do FACT-F evidenciaram a tendência para qualidade de vida satisfatória para os dois grupos de mulheres. O domínio bem-estar social foi o mais comprometido entre as mulheres que conservaram a mama e o bem-estar emocional obteve o melhor resultado. Já para as mulheres que retiraram a mama, o domínio bem-estar social foi o mais positivo e o bem-estar funcional o menos favorável. A fadiga esteve mais presente entre as mulheres submetidas a retirada da mama.CONCLUSÕES: Os resultados do estudo sugerem que o câncer de mama tem diferentes implicações na qualidade de vida da mulher.

Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo

IntroductionMethylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment.ObjectiveTo explore the efficacy of methylphenidate in the...

An exploratory analysis of extracellular vesicle-associated and soluble cytokines in cancer-related fatigue in men with prostate cancer

BackgroundCancer Related Fatigue (CRF) is one of the most prevalent and distressing symptoms associated with cancer treatments. The exact etiology of CRF and its mechanisms are poorly understood. Cytokine dysregulation was hypothesized to be one of these mechanisms. Here, we explored the associations of soluble and extracellular vesicle (EV)-associated markers that include cytokines, heat shock proteins (hsp27, hsp70, hsp90), and neurotrophic factors (BDNF) with CRF. MethodsPlasma was collected from men (n ​= ​40) with non-metastatic prostate cancer receiving external beam radiation therapy (EBRT) at the start of the treatment, and three months after EBRT. CRF was assessed using the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) from all participants. EVs were characterized via Nanoparticle Tracking Analysis, electron microscopy, and Western blot. Concentrations of EV-associated and soluble markers were measured with a multiplexed immunoassay system. Bivariate correlation analyses and independent T tests analyzed the relationships of CRF with the markers. FindingsAs CRF worsened, concentrations of EV-associated markers were upregulated. EV-associated fold changes of Eotaxin, hsp27, IP-10, MIP-3α, were significantly higher in fatigued participants compared to non-fatigued EBRT participants three months after treatment. This was not observed in soluble markers. Concentrations of EV-associated CRP and MCP-1, soluble survivin, IFNα2, IL-8, IL-12p70, and MCP-1 significantly correlated with lower (worsening) CRF scores at the start of and three months after treatment. InterpretationConcentrations of EV-associated markers increased in fatigued men with prostate cancer three months after EBRT. Both EV-associated and soluble markers correlated with worsening CRF. EV-associated markers, which have not been previously studied in depth, may provide additional insights and serve as potential biomarkers for CRF.

Brain-derived neurotrophic factor polymorphism Val66Met protects against cancer-related fatigue

Cancer-related fatigue is an extremely common and debilitating psychiatric symptom that affects up to 80% of cancer patients. Despite its negative impact on the patient’s quality of life, there is no well-established biomarker or mechanisms associated with this debilitating condition. The functional brain-derived neurotrophic factor (BDNF) Val66Met single nucleotide polymorphism (SNP) has been associated with a variety of psychiatric illnesses. We hypothesized that Val66Met may influence the risk for developing cancer-related fatigue. BDNF Val66Met was analyzed by polymerase chain reaction in 180 patients with confirmed cancer diagnoses. Fatigue was measured using the Functional Assessment of Cancer Therapy-Fatigue (FACIT-Fatigue) questionnaire. Depression was measured using the Hamilton Depression Scale (HAM-D). Data were transformed when necessary and regression models were constructed to access the association between genotype and symptom severity. Participants carrying the Met allele reported significantly less fatigue compared to the Val/Val genotype group. The presence of the Met allele did not influence depression levels. The results suggest that the BDNF Val66Met polymorphism confers protective advantage against cancer-related fatigue; whereas having the Val/Val genotype may be a genetic risk factor. Findings from this study not only provide clues to the neural basis of cancer-related fatigue, but also allow for symptom severity prediction and patient education with the goal to improve symptom management.

Exploring Biologic Correlates of Cancer-Related Fatigue in Men With Prostate Cancer: Cell Damage Pathways and Oxidative Stress.

The pathobiology of cancer-related fatigue (CRF) remains elusive, hindering the development of targeted treatments. Radiation therapy (RT), a common treatment for men with prostate cancer, induces cell damage through the generation of free radicals and oxidative stress. We hypothesized that disruption in cellular responses to this surge of nonphysiological oxidative stress might contribute to CRF in men with prostate cancer treated with RT. We evaluated the potential role of three cell damage pathways (apoptosis, autophagy, necrosis) and oxidative stress in CRF in men with prostate cancer receiving RT. Fatigue was measured by the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire. Gene expression was measured in whole blood using RT2 profiler™ PCR arrays. Data were collected at two time points: either baseline or Day 1 of treatment (T1) and completion of treatment (T2). Participants were grouped into either the fatigued or nonfatigued phenotype at T2 using the recommended FACT-F cut-off score for clinical significance. We observed significant upregulation of seven genes related to three cell damage pathways in the fatigued group from T1 to T2 and no significant changes in the nonfatigued group. We also observed significant downregulation of two genes related to oxidative stress in the fatigued group compared to the nonfatigued group at T2. These collective results provide preliminary evidence that cell damage might be upregulated in the CRF phenotype. Validation of these findings using a larger and more diverse sample is warranted.

Fatigue and Sleep Disturbance in Arabic Cancer Patients After Completion of Therapy: Prevalence, Correlates, and Association With Quality of Life.

Fatigue and sleep disturbance are 2 of the most common and distressing cancer symptoms that negatively affect quality of life. The aim of this study was to assess the prevalence of, and factors contributing to, fatigue and sleep disturbance in Arabic-speaking cancer patients in Oman after completion of their cancer treatment. A cross-sectional and descriptive correlational design was used. Data were collected using the Pittsburgh Sleep Quality Index where a score of >5 indicated as poorer sleep, the Functional Assessment of Cancer Therapy-Fatigue a score of ≤34 indicating clinically significant fatigue, and the Functional Assessment of Cancer Therapy-General. Of the 369 patients who participated, 77.5% (n = 286) reported clinically significant fatigue, and 78% (n = 288) reported poor sleep. Fatigue (P < .05) was significantly associated with age, cancer site, months since diagnosis, type of treatment received, and comorbidity. Those experiencing fatigue and poor sleep had the lowest quality of life among the cancer patients studied. Fatigue and sleep disturbance are significant problems for the Arabic patients diagnosed with cancer. Both fatigue and sleep disturbance should be routinely assessed in the case of such patients. Routine assessments of fatigue and sleep disturbance are recommended so that appropriate interventions and treatment management plans can be introduced to reduce fatigue and improve sleep quality among patients with cancer.

Effect of acupuncture on patients with cancer-related fatigue and serum levels of CRP, IL-6, TNF-α and sTNF-R1

To observe the therapeutic effect of acupuncture on cancer-related fatigue (CRF) and to explore its possible mechanism. A total of 80 patients with CRF were randomized into an observation group and a control group, and finally 67 patients completed the trial (36 patients in the observation group, 31 patients in the control group). Patients in the control group were treated with conventional chemoradiotherapy and symptomatic treatment, while no particular anti-fatigue intervention was adopted. On the basis of treatment in the control group, acupuncture was applied at Baihui (GV 20), Guanyuan (CV 4), Qihai (CV 6), Fengchi (GB 20), Zusanli (ST 36), Sanyinjiao (SP 6) in the observation group, once a day, 5 times as one course, with 2 days interval between each course, totally 4 courses were required. Before and after treatment, scores of functional assessment of cancer therapy-fatigue (FACT-F) in Chinese and McGill quality of life questionnaire (MQOL), serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α) and soluble TNF receptor-1 (sTNF-R1) were observed in the two groups. ①Compared before treatment, the FACT-F score was decreased after treatment in the observation group (P<0.05), while there was no significant difference in the control group (P<0.05). The change of the FACT-F score in the observation group was larger than that in the control group (P<0.05). ②In the observation group, scores of physiological and psychological dimension were decreased (P<0.05), score of social support dimension was increased after the treatment (P<0.05). The score changes of physiological, psychological and social support dimension in the observation group were larger than those in the control group (all P<0.05). ③After treatment, the serum levels of IL-6, TNF-α and sTNF-R1 were decreased in the observation group (P<0.05), while the serum levels of CPR and IL-6 were increased in the control group (P<0.05). The serum levels of CPR, IL-6 and TNF-α in the observation were lower than those in the control group (P<0.05). ①Acupuncture can improve the related symptoms of depression, weakness and headache in patients with CRF, strengthen their cognition of the support from society and family, and boost the confidence in curing the disease. ②Acupuncture can effectively down-regulate serum levels of the relative inflammatory factors, which may be its possible mechanism on treating CRF.

Cognitive and motor aspects of cancer-related fatigue.

BackgroundCancer‐related fatigue (CRF) is a debilitating symptom frequently reported by patients during and after treatment for cancer. CRF is a multidimensional experience and is often solely assessed by self‐report measures. The goal of the study is to examine the physical and cognitive aspects of self‐reported CRF using a cognitive function test and a physical fatigue index in order to provide objective measures that can characterize the CRF phenotype.MethodsA total of 59 subjects with nonmetastatic prostate cancer receiving external beam radiation therapy were included in the study. Fatigue was measured using the Functional Assessment of Cancer Therapy‐Fatigue (FACT‐F) questionnaire. Cognitive characteristics of CRF was measured using the Stroop Color‐Word Interference computerized test and the motor aspect of fatigue was measured using the static fatigue test using a handgrip dynamometer.FindingsFunctional Assessment of Cancer Therapy‐Fatigue scores significantly correlated with the Stroop Interference score, but not performance accuracy in all test conditions. Fatigued subjects exhibited a more rapid decline to 50% of maximal strength and increased static fatigue index in the handgrip test, whereas maximal grip strength was not affected.ConclusionsThe results suggest that CRF exhibits both cognitive and physical characteristics. Subjective fatigue was associated with increased time required to overcome cognitive interference, but not cognitive performance accuracy. Fatigued patients exhibited decreased physical endurance and the ability to sustain maximal strength over time. These objective measures may serve as valuable tools for clinicians to detect cognitive and physical impairment associated with CRF.

FIT: Functional and imaging testing for patients with metastatic cancer.

208 Background: Despite multiple cancer cachexia (CC) trials evaluating novel agents, the FDA has not approved a single drug to date. One key challenge in CC trials is selection of endpoints. The aim of this study was to explore changes in body composition and associations with functional and patient-reported outcomes (PROs) to clarify CC trial endpoint selection. Methods: We identified metastatic solid tumor cancer patients receiving cancer-directed therapies at a single cancer center (2016-2018). Patients completed all assessments at study enrollment and 3 months from enrollment. We analyzed body composition utilizing cross-sectional computed tomography (CT) scans at the third lumbar vertebra. Functional assessments included the 6-minute walk test (6MWT), Timed Up-and-Go (TUG) test, and Short Physical Performance Battery (SPPB). PROs included the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) and Functional Assessment of Cancer Therapy Fatigue (FACT-F). We examined changes in body composition and functional assessments from enrollment to 3 months using paired t-tests. We utilized linear regression models to assess the relationship between changes in body composition and changes in functional assessment adjusting for age and sex. Results: A total of 57 patients completed baseline assessments; 19 patients did not complete 3-month assessments (5 died, 1 hospice, 13 withdrew). Of the 38 patients with complete data (mean age 61.8 years, 47% female, 71% GI malignancy), 50% received chemotherapy, 16% immunotherapy, and 34% combination therapy. From enrollment to 3 months, we observed an increase in total adipose tissue (16.9±52.4 cm2, 95% CI -33.79-0.63; p = 0.059), but not weight or skeletal muscle. Greater losses in skeletal muscle were associated with greater declines in 6MWT (B = 0.036, p = 0.014) and SBBP (B = 2.444, p = 0.002), but not the TUG. We observed no association with change in weight with all functional outcomes or PROs. Moreover, we found no association with body composition and PROs from enrollment to 3 months. Conclusions: In future CC trials, changes in longitudinal body composition rather than weight should be utilized. Furthermore, changes in skeletal muscle and the 6MWT and/or SBBP may be preferred endpoints.

Modality-specific exercise guidelines and quality of life in kidney cancer survivors: A cross-sectional study.

Few exercise oncology trials have compared aerobic with strength exercise or compared combined exercise (ie, aerobic and strength training) with aerobic only or strength only. It is unknown what single or combined exercise modality is optimal for quality of life (QoL) in cancer survivors. The purpose of this study is to estimate the prevalence of meeting the combined and independent aerobic and strength exercise guidelines in kidney cancer survivors (KCS) and determine any associations with QoL. One thousand nine hundred eighty-five KCS were identified through a provincial registry in Canada and mailed a survey including exercise and QoL scales. Completed surveys were received from 703 KCS. Only 10.1% of KCS reported meeting the combined exercise guidelines. Analyses of covariance indicated that, for most QoL outcomes (eg, Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Fatigue), meeting the combined exercise guideline was superior to meeting either single modality guideline that, in turn, were superior to meeting neither guideline. For the primary outcome of the Trial Outcome Index-Fatigue, meeting the combined exercise guideline was superior to meeting (a) neither guideline (P<0.001), (b) the strength-only guideline (P=0.021), and (c) the aerobic-only guideline (P=0.051). In turn, the aerobic and strength exercise only guidelines were superior to meeting neither guideline (P<0.001 for aerobic; P=0.045 for strength) but were not different from each other (P=0.50). Meeting the combined exercise guideline has favorable associations with QoL in KCS, however, very few KCS are meeting the combined guideline.

Music Therapy Reduces Radiotherapy-Induced Fatigue in Patients With Breast or Gynecological Cancer: A Randomized Trial.

Purpose: To investigate the influence of music therapy on the reduction of fatigue in women with breast or gynecological malignant neoplasia during radiotherapy, since it is one of the most frequent side effects of this type of treatment, and may interfere with self-esteem, social activities, and quality of life. Experimental Design: Randomized controlled trial (control group [CG] and music therapy group [MTG]) to assess fatigue, quality of life, and symptoms of depression in women undergoing radiotherapy using the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) version 4, Functional Assessment of Cancer Therapy–General (FACT-G) version 4, and Beck Depression Inventory in 3 separate times, namely, during the first week of radiotherapy, on the week of the intermediary phase, and during the last week of radiotherapy. Individual 30- to 40-minute sessions of music therapy with the presence of a trained music therapist were offered to participants. Results: In this study, 164 women were randomized and 116 (63 CG and 53 MTG) were included in the analyses, with mean age of 52.90 years (CG) and 51.85 years (MTG). Participants in the MTG had an average of 10 music therapy sessions, totaling 509 sessions throughout the study. FACT-F results were significant regarding Trial Outcome Index (P = .011), FACT-G (P = .005), and FACT-F (P = .001) for the MTG compared with the CG. Conclusions: Individual music therapy sessions may be effective to reduce fatigue related to cancer and symptoms of depression, as well as to improve quality of life for women with breast or gynecological cancer undergoing radiotherapy. Further well-designed research studies are needed to adequately determine the effects of music therapy on fatigue.