Clinical Trials Logo

Clinical Trial Summary

Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that can persist for months or years in cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. However, exercise interventions have not been tailored to alleviate CRF in fatigued cancer survivors, and thus the potential to alleviate CRF may not have been realized. The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.


Clinical Trial Description

Background and Rationale Approximately one-third of cancer survivors experience severe and persistent fatigue for a number of years post-treatment, but this distressing symptom is often under-treated by healthcare professionals due to a lack of mechanism-targeted interventions. The assessment of cancer-related fatigue (CRF) is reliant on subjective fatigue measurements such as self-report questionnaires. Less attention has been given to objective physiological measurements. However, there are well-established techniques which allow the assessment of neuromuscular fatigue and its peripheral and central origins which could be utilized in the study of CRF. Very few studies have considered these objective measures alongside self-report scales in the study of CRF and only two have used such techniques in cancer survivors. To date, no studies have investigated neuromuscular fatigue in whole body, dynamic activity as relevant to daily tasks (and involving the lower limb due to its functional relevance to locomotion). Novel testing developed in our laboratory could be used as part of a wider screening to develop individualized interventions to alleviate CRF. It is well accepted in the field that CRF is multidimensional and in addition to a potential neuromuscular component, the role of sleep disturbance may also be implicated. Interventions targeted at improving sleep quality are therefore warranted, and there is sound evidence for the efficacy of exercise interventions in particular for improving CRF in cancer survivors. As a non-pharmacological intervention, physical activity has the strongest evidence base for treating CRF. However, the mechanisms explaining the reduction of CRF with exercise are not understood. Due to the complex and multi-factorial nature of CRF, it would be of benefit to tailor exercise interventions to the specific deficits (in regards to neuromuscular mechanisms) or difficulties (for example sleep disturbance) experienced by the individual. Ultimately, mechanism-targeted exercise interventions could be translated to clinical rehabilitation programs and lead to an improved quality of for cancer survivors. Research Question & Objectives The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity. Methods Fatigued cancer survivors who have completed primary treatment ≥ 3 months and ≤ 5 years from enrollment will be randomly allocated to one of two 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 published recommendations. The tailored exercise group will be prescribed an intervention designed to address individual deficits (identified at baseline) that may be related to CRF. Participants will be assessed before and after the intervention for 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03049384
Study type Interventional
Source University of Calgary
Contact
Status Completed
Phase N/A
Start date March 9, 2017
Completion date March 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05428527 - Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue
Completed NCT04563013 - Study of the Effects of Transcutaneous Vagus Nerve Stimulation on Cancer Patients N/A
Recruiting NCT05613465 - Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo N/A
Recruiting NCT05448573 - A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening
Completed NCT03897556 - Effect of High-Dose Guarana And Cancer-Related Fatigue N/A
Recruiting NCT04147312 - Fufang E'Jiao Jiang Intervening Cancer-related Fatigue N/A
Active, not recruiting NCT03318224 - Fatigue Prevalence, Severity, and State of Treatment in Germany
Completed NCT01720550 - PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care Phase 4
Not yet recruiting NCT06381557 - Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules Phase 4
Completed NCT05009693 - Effect of White Light on Fatigue Levels in Patients With Gynecological Cancer N/A
Withdrawn NCT03211273 - Longitudinal Investigation of Cancer-related Fatigue
Recruiting NCT02661308 - Reducing Cancer Side-effects With Systematic Light Exposure N/A
Completed NCT02740959 - Effects of PG2 on Fatigue-Related Symptom Clusters N/A
Completed NCT03314805 - PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy Phase 2
Completed NCT03553355 - Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients N/A
Recruiting NCT05440227 - PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients Phase 2
Enrolling by invitation NCT01228773 - The Efficacy of Health Navigation® for Cancer-Related Fatigue in Cancer Survivors Phase 2
Not yet recruiting NCT04947969 - Clinical Effect of Laser Acupuncture on Improving Cancer-related Fatigue N/A
Not yet recruiting NCT00552552 - Development and Evaluation of a Cancer-Related Fatigue Patient Education Program N/A
Active, not recruiting NCT05390398 - Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention N/A