Treatment Of Fatigue In Patients Research Articles

Diagnosis and treatment of fatigue in patients with inflammatory bowel disease

Diagnosis and treatment of fatigue in patients with inflammatory bowel disease

Cognitive behavioural therapy for fatigue in patients with multiple sclerosis: A systematic review and meta-analysis

BackgroundTreatment of fatigue is important for many patients with multiple sclerosis (MS). While pharmacological options have not shown consistent benefit, psychological interventions offer another avenue of treatment. Cognitive behavioural therapy (CBT) involves strategies to change maladaptive cognition and illness behaviours that modulate how patients with MS respond to fatigue. The aim of this study was to perform a systematic review and meta-analysis to determine the effectiveness of CBT for the treatment of fatigue in patients with MS. MethodsFive databases (Cochrane Central Register of Controlled Trials, MEDLINE/PubMed, Embase, Emcare and PsycINFO) were searched up until 31 July 2023. Randomised controlled trials involving adult patients with MS and fatigue, comparing CBT with another intervention or usual treatment were included. Studies were required to measure fatigue severity and/or the impact of fatigue as the primary outcome(s). Each study was assessed for bias using the Cochrane Risk of Bias tool version 2. Studies with sufficient data were used for meta-analysis to quantify the short- and long-term effects of CBT on MS-related fatigue. The level of certainty provided by the body of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. ResultsEight studies were included in the review and six studies contributed to the meta-analysis. Most studies had a low overall risk of bias. CBT interventions differed in the number, duration and frequency of sessions, mode of delivery and therapist. There were significant short- (standardised mean difference (SMD) -0.58, 95% confidence interval (95%CI) -0.85 to -0.31, P-value < 0.0001) and long-term (SMD -0.36, 95%CI -0.52 to -0.19, P-value < 0.0001) effects supporting CBT. The evidence provided a low level of certainty for the short-term effect because of heterogeneity of results and possible publication bias, while there was high certainty for the long-term result. ConclusionThe study provides secondary evidence that CBT has moderate short-term and small long-term effects in reducing fatigue in patients with MS. CBT should be regarded as a viable evidence-based intervention, particularly in the absence of established alternatives. Future research should identify the ideal characteristics of a fatigue-specific CBT intervention, patient factors that predict treatment response and strategies to maintain initial improvements over time.

P742 The efficacy of comprehensive multivitamin and mineral supplement to treat symptoms of fatigue in patients with Inflammatory Bowel Disease in remission with immunomodulators and or biological agents

Abstract Background Patients with inflammatory bowel disease(IBD) very often report feeling tired for no reason. Malnutrition and vitamin or mineral deficiencies are also very common among patients with IBD. The aim of this study was to evaluate the efficacy of a multivitamin and mineral supplement for the treatment of fatigue in patients with IBD. Methods Single-centre, randomized placebo-controlled clinical trial to compare a comprehensive over-the-counter multivitamin and mineral supplement (supplemented group) with an identical presented placebo (placebo group) for the treatment of fatigue. Non-vitamin deficient patients with IBD in remission with immunomodulators and/or biological therapy were asked to report score their fatigue on a Visual Analog Scale (0-10) and the validated Chalder fatigue questionnaire (CFQ) at baseline, week 12 and 24. The validated CFQ has a scoring range from 0-33 and 2 subscales physical and psychological fatigue. Patients were considered to be fatigued by the CFQ with a score of 12 or above. Results A total of 214 patients reported fatigue at the start of the study. Of these patients 115 and 99 were assigned to the supplement and placebo groups, respectively. In the supplemented and placebo group, 32 (34%) and 18 (21%) patients, respectively, experienced no fatigue according to the CFQ definition at 24 weeks (Unadjusted Odds Ratio (OR): 2.0 (95% Confidence Interval (CI):1 - 3.8). In particular patients with Ulcerative Colitis (UC) and supplement use experienced less fatigue at 24 weeks (OR 5.7 (95% CI:1.3 - 24.1). Improvement of fatigue experienced between baseline and 24 weeks was not statistical different for either the supplemented and placebo group. Conclusion Although improvement in fatigue score was limited, a significant number of patients with IBD in remission with immunomodulators, and/or biological therapy using a very comprehensive vitamin and mineral supplement reported improvement of fatigue after 24 weeks of use.

Screening Single Nucleotide Polymorphisms Predicting the Efficacy of Electroacupuncture for Fatigue Treatment in Patients with Breast Cancer Following Adjuvant Chemotherapy.

Chemotherapy-induced fatigue reduces not only the quality of life of patients but also effect their recurrence-free survival rate. Although electroacupuncture can relieve fatigue, it has limited affect on some patients. Therefore, appropriate biomarkers are needed to help screen patients who can benefit from electroacupuncture treatment of fatigue. We conducted this study to explore the predictive ability of SNPs on the efficacy of electroacupuncture in the treatment of fatigue in patients with breast cancer after adjuvant chemotherapy. Our study included breast cancer patients with fatigue after receiving paclitaxel and/or anthracycline based adjuvant chemotherapy. The patients were divided into the electroacupuncture group and the control group. The electroacupuncture treatment group received adjuvant chemotherapy and electroacupuncture treatment, while the control group only received adjuvant chemotherapy, and then compared the fatigue relief degree of two groups. In addition, we used NCBI dbSNP and PharmGKB databases to select fatigue related genes and their SNPs. We collected peripheral blood from the included patients for SNPs typing, and recorded the efficacy of electroacupuncture to analyzed the correlation between different SNPs and therapeutic efficacy. The side effects of electroacupuncture treatment were also recorded. 76 patients in the electroacupuncture group and 48 patients in the control group were enrolled. In the electroacupuncture group, 63 patients (82.9%) experienced moderate to severe fatigue (BFI score > 3). After electroacupuncture treatment, the number of patients with a BFI score of > 3 was 46 (60.5%). Therefore, the fatigue symptoms of 26.9% patients were significantly improved (P < 0.05). In the control group, which did not receive electroacupuncture treatment, 40 of 48 patients had a BFI score of > 3. Following the same observation time used in the electroacupuncture group, 36 patients had a BFI score of > 3 points. Thus, fatigue was not significantly relieved in the control group (83.3% vs. 75.0%, P > 0.05). We included 56 patients in our analysis of the correlation between SNPs and electroacupuncture treatment effects. We divided the patients into an effective group and ineffective group according to therapeutic effects. Our results indicated that the effective rate of electroacupuncture treatment with IL1A rs3783550 AC and CC genotypes was higher than that with other genotypes (AC: 84.6%, CC: 81.8%, AA: 33.0%, P < 0.05). Similarly, the effective rate of electroacupuncture treatment with HTR1A rs6295 GG and CC genotypes was higher than that with other genotypes (GG: 63.0%, CC: 55.6%, GC: 18.2%, P < 0.05). However, no other genotypes were related to the effect of electroacupuncture treatment on fatigue. Our result showed that electroacupuncture has therapeutic effect on fatigue after adjuvant chemotherapy for breast cancer and the side effects are tolerable. In addition, IL1A rs3763550 and HTR1A rss6295 can predict the therapeutic effect of electroacupuncture on fatigue after adjuvant chemotherapy in breast cancer, which helps to better screen patients who can benefit from electroacupuncture treatment.

Pharmacological and Behavioral Interventions for Fatigue in Parkinson's Disease: A Meta-Analysis of Randomized Controlled Trials.

This study aims to evaluate pharmacological and behavioral interventions for the treatment of fatigue in Parkinson's disease (PD) patients. We systematically searched PubMed, PsycINFO, Web of Science, EMBASE, CNKI, Wan fang, and VIP up to July 31, 2022. We used Revman 5.3 software for the meta-analysis. The outcomes included Fatigue Severity Scale (FSS) and Parkinson's Fatigue Scale (PFS). The mean difference (MD) and 95% confidence intervals (CI) were collected or calculated. Thirteen randomized controlled trials (RCTs) with a total of 1758 patients were included. The meta-analysis showed that current clinical treatments reduced FSS (MD: -1.60, 95% CI: -3.14 to -0.05) and PFS (MD: -0.61, 95% CI: -1.17 to -0.05) in patients with PD. Subgroup meta-analysis showed that: (1) neither pharmacological interventions nor behavioral interventions reduced FSS in PD patients; (2) dopaminergic drugs dose-dependently significantly reduced the PFS in patients with PD; (3) behavioral interventions have an almost significant effect (MD: -6.69, 95% CI: -13.71 to 0.33, P = 0.06, I2 = 74%) on alleviating PFS in PD patients; (4) vestibular rehabilitation training significantly reduced the PFS in patients with PD. Current clinical treatments alleviate fatigue in PD patients. Dopaminergic drugs may act a stronger effect than amphetamines. Behavioral interventions, especially vestibular rehabilitation training, may be a promising way for the treatment of fatigue in patients with PD though further evidence is still needed.

Efficacy of cognitive-behavioural psychotherapy in the treatment of chronic fatigue in patients with multiple sclerosis – a literature review

Fatigue is one of the most common symptoms seen in patients with multiple sclerosis. Cognitive-behavioural psychotherapy can be a non-pharmacological approach for these patients. Van Kessel and Moss-Morris developed a cognitive-behavioural model to explain multiple sclerosis-related fatigue (2006). According to this model, inflammatory and demyelinating factors present in the central nervous system trigger fatigue, while cognitive interpretation, anxiety, or depressive symptoms and resting lifestyle are maintaining factors. Based on the cognitive-behavioural model of fatigue in multiple sclerosis, a protocol encompassing 8 treatment sessions was developed. For over 10 years, studies have been conducted to verify the effectiveness of cognitive-behavioural psychotherapy in the treatment of fatigue in patients with multiple sclerosis. The so far obtained results show that cognitive-behavioural psychotherapy has a moderate short-term effect on reducing fatigue, while the effect size in the long-term is small. The obtained results were undoubtedly influenced by several factors: the heterogeneity of the procedures used, the size of the research groups, and the large number of disease-related intermediary variables. Further research should be conducted to identify specific factors responsible for the effectiveness of cognitive-behavioural psychotherapy in the treatment of fatigue and to assess the long-term effects of therapy.

Effects of Sensory Interventions on Fatigue in People With Multiple Sclerosis: A Systematic Review.

Fatigue is 1 of the most common and annoying symptoms in patients with multiple sclerosis (MS). The purpose of this study was to investigate the effect of sensory interventions on fatigue in people with MS based on a systematic review of sensory evidence. The Google Scholar, PubMed, Scopus, and Cochrane Library databases were searched from January 1990 to July 2020. Studies with nonpharmacologic sensory interventions as a main or secondary intervention according to the assessment of fatigue as the primary or secondary therapy outcome in patients with MS were included. Nine articles were reviewed by examining the inclusion and exclusion criteria. Four types of interventions were related to exercises, including sensory integration exercises, vestibular rehabilitation, Frenkel exercises, and exercises with or without vibration; and 2 types were performed using robots and 1 type using vibration only. Vestibular rehabilitation therapies, exercise-based sensory integration interventions, and the use of vibration have shown significant effects in relieving fatigue in patients with MS. The evidence in this study is insufficient to show a dramatic effect of sensory integration therapy in various forms. However, despite the studies, sensory integration therapy can be considered a potential treatment for fatigue in patients with MS. Further studies with stronger methods are needed to make this treatment a reality.

Comparison of the effects of amantadine and ondansetron in treatment of fatigue in patients with multiple sclerosis

BackgroundMultiple sclerosis (MS) is a common neurological disorder with a variety of manifestations including fatigue. Fatigue may interfere with daily work and activities. Different pharmacological and non-pharmacological methods have been used for treatment of this symptom in MS patients. In this study, the effect of ondansetron and amantadine in the treatment of fatigue was compared.MethodsIn this randomized clinical trial, 53 MS patients with fatigability were enrolled (mean age ± standard deviation: 54.00 ± 7.88, Female/male ratio: 45/8). Patients were referred to Imam Clinic and Sina Hospital, Hamadan, Iran. Patients were assessed using the Fatigue Severity Scale (FSS) questionnaire. Patients were randomly assigned to either the amantadine or ondansetron treatment groups and received treatments in a crossover manner. The severity of fatigue was measured using FSS questionnaire in four stages (beginning and end of each regimen). Data were analyzed using SPSS software version 16.ResultsThe mean and standard deviation of patients’ fatigue scores before treatment were 43.07 ± 10.36 and 43.22 ± 9.67 in the amantadine and ondansetron group, respectively. These scores were 37.36 ± 7.87 and 40.00 ± 8.94 after treatment in the amantadine and ondansetron group, respectively. Both drugs significantly decreased the fatigue severity of patients (P < 0.001). There was no statistically significant difference between two regimens in terms of the mean score of fatigue before and after treatment and the frequency of complications. However, when ranking the severity of fatigue (mild, moderate, severe), fatigue reduction after intervention in the amantadine group was significantly higher than ondansetron (P = 0.026).ConclusionBoth amantadine and ondansetron reduce fatigue in MS patients, but the efficacy of amantadine in reducing the MS-associated fatigue is greater than that of ondansetron.

An N-of-1 Feasibility Study of Homeopathic Treatment for Fatigue in Patients Receiving Chemotherapy.

Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested. A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures. Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy. Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design.

Modulation of Cortico-Subcortical Functional Connectivity Occurs After Symptomatic Treatment of Fatigue in Patients with Multiple Sclerosis (P3.384)

Modulation of Cortico-Subcortical Functional Connectivity Occurs After Symptomatic Treatment of Fatigue in Patients with Multiple Sclerosis (P3.384)

An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy

An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy

Potential Role of Bupropion Sustained Release for Cancer-Related Fatigue: a Double-Blind, Placebo-Controlled Study

Background:Cancer-related fatigue (CRF) is very common and can be experienced at all stages of disease and in survivors. CRF causes patients more distress than pain or nausea and vomiting. Different pharmacologic interventions have been evaluated for the management of CRF. The purpose of this study was to determine the efficacy of bupropion sustained release (SR) as a treatment for fatigue in patients with cancer.Methods:In this randomized, double-blind, placebo-controlled trial, patients with fatigue due to cancer were randomly assigned to either 150mg daily of bupropion SR or matching placebo. The primary endpoint was the changes in average daily fatigue from baseline to week 4 using the Functional Assessment of Chronic Illness-therapy- Fatigue (FACIT-F) questionnaire.Results:40 patients were randomly assigned to treatment with bupropion SR or placebo (20 in each group). Analysis of covariance (ANCOVA) showed a significant improvement in fatigue and quality of life in the bupropion group compared to baseline (P=0.000). Secondary outcome, including depression, severity of fatigue and performance status didn’t show significant difference between groups. Generally, bupropion SR was tolerated well.Conclusion:Four weeks of 150 mg bupropion SR improve fatigue significantly in cancer patients. Bupropion has potential as an effective and safe pharmaceutical agent for treating CRF.

Adalimumab impact on fatigue measured by FACIT-F: a study of rheumatoid arthritis patients in Saudi Arabia.

ObjectiveThe objective of the study was to assess the effectiveness of adalimumab as a treatment for fatigue in patients with rheumatoid arthritis (RA).MethodsFatigue was monitored in patients with RA who were already on an adalimumab treatment regimen. Fatigue, general well-being, comorbidities, and disease activity were measured at baseline and ~8, 16, and 24 weeks, thereafter.ResultsSignificant reductions in fatigue scores and disease activity were observed from baseline to 6 months after. A predictive regression model of fatigue severity was proposed and was found to be significant, with RA disease activity as the most significant predictor of fatigue severity.ConclusionThis quasi-experimental study is a good starting point for research on the efficacy of adalimumab in treating fatigue in RA patients. The results here suggest that a randomized controlled trial assessing adalimumab as a treatment option for RA patients suffering from fatigue is warranted.

Predictors of fatigue among individuals with primary immune thrombocytopenia in China

目的研究成人原发免疫性血小板减少症（ITP）患者疲劳症状，分析疲劳严重程度的影响因素。方法采用中文版慢性病治疗功能评估疲乏量表（FACIT疲劳量表）、匹兹堡睡眠质量指数（PSQI）、医院焦虑抑郁量表（HADS）及一般情况调查表对就诊于中国医学科学院血液病医院的成人ITP患者进行调查研究，运用多元线性回归分析方法筛选影响疲劳严重程度的相关因素。结果共纳入207例ITP患者，中位年龄42（18~72）岁，男70例（33.8%），女137例（66.2%），总体FACIT疲劳量表得分为（37.50±9.05）分。ITP患者FACIT疲劳量表得分与血小板计数呈正相关（r=0.307，P<0.001），与出血严重程度、睡眠质量、抑郁情绪、焦虑情绪呈负相关（r值分别为−0.276、−0.654、−0.598、−0.616，P值均<0.001）。多因素线性回归分析显示，血小板计数（P<0.001）、出血程度（P=0.004）、睡眠质量（P<0.001）、抑郁情绪（P<0.001）与ITP患者的疲劳严重程度显著相关，血小板计数偏低、出血程度越重、睡眠质量越差、抑郁情绪越明显，提示疲劳程度越严重。结论ITP患者的疲劳症状受多种因素影响，改善睡眠质量、消除抑郁情绪、提高血小板数目、改善出血症状等措施有助于缓解疲劳程度。

A Randomized, Placebo-Controlled Clinical Trial of Efficacy and Safety: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis.

Fatigue is a common symptom of primary biliary cirrhosis (PBC), and is associated with an impaired quality of life. No studies have assessed the use of modafinil in fatigue related to PBC in a controlled manner. A randomized, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of modafinil for the treatment of fatigue in PBC. Forty patients were randomized to modafinil (n = 20) or placebo (n = 20) for 12 weeks. A verbal report of fatigue for at least 6 months was required for enrollment. Modafinil was administered at 100 mg by mouth once daily; a change by 50 mg every 2 weeks (maximum: 200 mg once daily) was allowed, depending on the subject's response to treatment. The primary outcome was defined as a ≥50% improvement in fatigue severity [quantified by the Fisk Fatigue Impact Scale (FFIS)] after 12 weeks of treatment, compared with baseline values. Thirty-three PBC patients completed the study. After 12 weeks of therapy, only 5 patients had a ≥50% reduction in FFIS scores: 3 patients (17.6%) in the modafinil arm and 2 (12.5%) in the placebo arm (P = 1.00). Change in median FFIS score was not statistically different between patients in the 2 treatment groups (P = 0.36). Modafinil was associated with minimal adverse events (headaches, diarrhea, and rash). In patients with PBC who have fatigue, treatment with modafinil for 12 weeks was safe and fairly well tolerated; however, it did not result in beneficial effects on fatigue compared with patients treated with placebo (CONSORT Table 1). ClinicalTrials.gov identifier NCT00943176.

How to manage fatigue in fibromyalgia: nonpharmacological options.

The aim of this article is to suggest recommendations for the management of fatigue in fibromyalgia (FM) by reviewing and compiling findings of nonpharmacological treatment for fatigue in patients with FM. The management of fatigue in FM should incorporate regular physical exercise maintained for a longer period of time, which contributes to improved general health and facilitates coping with fatigue and other symptoms. The evidence is still low and the effect of exercise on fatigue in FM needs to be further studied. Patients with FM appear to benefit from general sleep hygiene advice and also need to develop individual strategies to manage the complex factors in everyday life that may be related to fatigue.

The Pathophysiology of Fatigue in Parkinson's Disease and its Pragmatic Management.

Fatigue is 1 of the most common and most disabling symptoms among patients with Parkinson's disease (PD) and has a significant impact on their quality of life. Yet the pathophysiology of fatigue is poorly understood, while its treatment is "limited to an empirical approach based on plausible hypotheses." PubMed was searched for articles with the key words "Parkinson's disease" or "parkinsonism" and "fatigue" that were published by or before August 2015. The analysis of articles, which were selected on subjective grounds, was used to review the current knowledge of pathophysiology and treatment outcomes in studies focused on fatigue in PD. Clinical and experimental findings support the view that fatigue is a primary manifestation of PD. The main hypothesized pathophysiological mechanisms include abnormal basal ganglia (BG)-cortical mechanisms, particularly frontal loops, and an imbalance between neurotransmitters (e.g., dopamine [DA] and serotonin), along with an altered hypothalamus-pituitary-adrenal axis, neuroinflammation, cardiac sympathetic denervation, etc. Pragmatic treatment of fatigue in patients with PD includes various pharmacological (dopaminergic and psychostimulant drugs, antidepressants) and nonpharmacological strategies, although current knowledge suffers from insufficient evidence to support the use of any drug or nondrug therapy.

Effectiveness of Modafinil on Fatigue in Chronic Hepatitis C

Introduction: Objective: To assess the efficacy of modafinil on fatigue in patients with Chronic Hepatitis C. Background: Hepatitis C Virus (HCV) is present in about 8% of the veteran population. Fatigue accompanies HCV infection in 53%-67% of patients and is sufficiently severe enough to impair activity in 17%. Modafinil is a unique wake-promoting agent that has been found to be effective in the treatment of fatigue in patients with multiple sclerosis. Methods: Patients aged 18-65 years with a diagnosis of HCV and mean score >27 on the fatigue severity scale (FSS) were eligible for the randomized double-blind placebo controlled trial. Exclusion criteria included hemoglobin <12, total bilirubin >2, uncontrolled diabetes with HBA1c >8, congestive heart failure with EF <35%, malignancy, or pregnancy. Patients received either placebo or 100 mg of modafinil for 2 weeks. Efficacy was evaluated with self-rating scales: fatigue severity scale (FSS) [score= 9-63], Epworth sleep scale (ESS) [score=0-24], and CES-D depression scale [score=0-60]. Change scores were calculated as pre-score minus post-score. Adverse events were also recorded. The independent samples t-test was used to compare groups on change scores. Results: Of the 25 patients enrolled, 4 were lost to follow-up. Eleven patients received modafinil and 10 received placebo. Ten patients in each group completed all outcome measures. No significant improvement in fatigue, sleep, or depression was demonstrated. FSS decreased 7.4 for the modafinil group (pre=50.2, post=42.8) vs. 6.4 for the placebo group (pre=48.9, post 42.5) [p=0.87]. ESS decreased 2.5 for the modafinil group (pre=12.3, post=9.8) vs. 0.8 for the placebo group (pre=10.9, post 10.1) [p=0.38]. CES-D decreased 5.35 for the modafinil group (pre=24.0, post=18.65) vs. 1.9 for the placebo group (pre=25.4, post 23.5) [p=0.36]. Serious adverse events were not found. The most common adverse events were headache and nausea. Conclusion: While 100 mg modafinil daily did not improve fatigue, sleep, or depression compared to placebo, our study was an exploratory study with limited power (n=10 for each group). We showed the feasibility of such a study (i.e., low dropout rate and no serious adverse events) and recommend a future investigation with a larger sample to determine the effectiveness of modafinil to reduce fatigue in HCV patients. The lack of improvement in fatigue in the modafinil group may have also been due to lower dose of modafinil used.

AB0451 The efficacy of anti-tumor necrosis factor therapy and the factors which contribute to fatigue in rheumatoid arthritis

BackgroundFatigue is an important domain in the assessment of disease impact but has rarely been evaluated consistently after initiation of treatment in Rheumatoid Arthritis (RA) patients. Due tothe known efficacy...

Multimodal therapy for the treatment of fatigue in patients with prostate cancer receiving androgen deprivation therapy and radiation.

TPS9650 Background: Cancer-related fatigue (CRF) is the most frequently reported symptom associated with cancer and its treatment. Unfortunately, there are limited treatment options to alleviate this distressing symptom. Preliminary data suggest that the combination of exercise, cognitive behavioral therapy (CBT), and methylphenidate (that is, multimodality therapy [MMT]) can play an important role in reducing CRF. The project’s objective is to explore the effects and safety of this MMT on CRF in prostate cancer patients scheduled to receive radiotherapy with androgen deprivation therapy. We hypothesizethat the MMT is capable of reducing CRF as measured by the FACIT-F subscale in prostate cancer patients scheduled to receive radiotherapy. Specific Aims:(1) Our primary aim is to obtain preliminary estimates of the effects of various treatments (exercise, CBT, and methylphenidate) and their combinations in reducing CRF in prostate cancer patients receiving radiotherapy, as measured by the change in patients’ FACIT-F subscale scores taken at baseline and on day 57 and the secondary objective is to determine the effects of the treatments and their combinations on anxiety and depressed mood (both measured by the Hospital Anxiety Depression Scale [HADS]); on physical activity and function (measured by an accelerometer and a handgrip dynamometer, respectively); on levels of inflammatory cytokines (IL-1β, IL-6, TNF-α, and IL-10) in serum and induced monocytes, before and after treatment Methods: For this study, we will use a randomized factorial design to assess 3 treatments (exercise, CBT, and methylphenidate) and their placebos in 8 replications. A total of 32 patients will receive each primary treatment and 32 will not. Patients will be studied for a 57-day period, during which they are scheduled undergo daily radiation treatments with androgen deprivation therapy. Fatigue, anxiety and depressed mood, and inflammatory cytokines will be determined at baseline and at 3 subsequent post-intervention assessments. After successful initiation so far 19/64 patients were enrolled. Accrual continues. Clinical trial information: NCT01410942.