Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial

Abstract

BackgroundCancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that persists for years after treatment completion in approximately one third of cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. There are multiple potential pathways by which exercise improves CRF, and cancer survivors with CRF are diverse with respect to cancer type, treatments and experienced side effects. While the general exercise guidelines are likely sufficient for most cancer survivors, tailoring of exercise interventions may be more effective in those with persistent fatigue. The primary aim of this research is to investigate the effect of a traditional vs. tailored exercise intervention on CRF severity in cancer survivors with persistent CRF.Methods/designCancer survivors (≥ 3 months and ≤ 5 years since primary treatment) who score ≤ 34 on the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) will be randomly allocated to one of two parallel treatment arms: traditional (active control) and tailored exercise. Participants in the traditional exercise group will engage in aerobic and resistance exercise that is consistent with exercise guidelines for cancer survivors. The tailored exercise group will be prescribed an intervention designed to address individual deficits identified at baseline, such as loss of muscular strength, cardiorespiratory deconditioning or sleep disturbance. Participants will be assessed before and after the intervention for CRF severity and other patient-reported outcomes, neuromuscular function and fatigue in response to whole-body exercise, sleep quantity and quality, physical activity levels, cardiorespiratory fitness and blood biomarkers.DiscussionTo our knowledge, this will be the first study to compare the effects of a traditional vs. tailored exercise intervention on CRF severity in cancer survivors with persistent CRF. Using physiological, behavioural and patient-reported outcomes, this study will add to the current knowledge about both the factors contributing to CRF, and the potential reduction in CRF severity with an exercise intervention.Trial registrationThe study is registered at ClinicalTrials.gov (NCT03049384), February, 2017.Electronic supplementary materialThe online version of this article (10.1186/s12885-018-4668-z) contains supplementary material, which is available to authorized users.

Post-Exertional Malaise in People with Chronic Cancer-Related Fatigue

“…Participants were recruited as part of an ongoing prospective randomized controlled trial (ClinicalTrials.gov, NCT03049384 and [26]). The purpose of the RCT is to investigate the .…”

“…Participants were excluded if they had a contraindication to experimental procedures and/or exercise. Additional inclusion and exclusion criteria have been reported previously, and include exclusion for sleep apnea or anemia [26]. A medical history was taken to account for conditions that may explain/contribute to fatigue.…”

“…Full details of the wider project have been reported elsewhere [26]. The data for this sub-study were collected during and after an initial visit to the laboratory, previously described as Lab Visit #1 [26].…”

“…Otherwise, participants were cleared for participation by a Certified Exercise Physiologist (Canadian Society for Exercise Physiology). Details of the maximal exercise test protocol have been reported in detail elsewhere [26]. Data collected during the test and used for the main study (e.g.…”

Cardiopulmonary exercise testing for the measurement of maximal oxygen uptake in people with cancer-related fatigue: a retrospective analysis

“…Randomized clinical trials continue to build evidence for exercise in under-represented tumour groups [3], as cancer prehabilitation [4], and in subsets of people with complex and long-term adverse effects, e.g. chronic CRF [5]. Alongside the benefits of exercise reported by patients, such as the ability to preserve normality and reclaim the body [6], improvements in objective physiological measures, including measures of cardiorespiratory fitness, are of interest.…”