Clinical trial NCT03049384: Tailored Exercise Interventions to Reduce Fatigue in Cancer Survivors
Official title: Tailored Exercise Interventions to Reduce Fatigue in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Fatigue
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2017-02-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 75 years;
* Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score ≤ 34;
* Completion of treatment in ≥ 3 months and ≤ 5 years preceding enrollment;
* Approval received from personal physician and/or a Canadian Society for Exercise Physiology-Clinical Exercise Physiologist (CSEP-CEP);
* Command of the English language.

Exclusion Criteria:

* Contraindication to experimental procedures including transcranial magnetic stimulation (TMS);
* Diagnosed as having obstructive sleep apnea or anemia;
* Currently participating in a structured exercise intervention;
* Participant is pregnant.

Primary outcomes:
measure: Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
timeFrame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up.
Secondary outcomes:
measure: Assessment of change in The Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in Edmonton Symptom Assessment System-revised tiredness scale
timeFrame: Baseline and after the 12-week intervention, and during follow up (6 and 12 months).
measure: Maximal Isometric Force in the Knee Extensors
timeFrame: Baseline and after the 12-week intervention.
measure: Cortical Voluntary Activation
timeFrame: Baseline and after the 12-week intervention.
measure: Voluntary Activation
timeFrame: Baseline and after the 12-week intervention.
measure: Potentiated Doublet Twitch Force
timeFrame: Baseline and after the 12-week intervention.
measure: Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
timeFrame: Baseline and after the 12-week intervention.
measure: Muscle Compound Action Potential (M-Wave) Peak-to Peak Duration
timeFrame: Baseline and after the 12-week intervention.
measure: Muscle Compound Action Potential (M-Wave) Area
timeFrame: Baseline and after the 12-week intervention.
measure: Motor Evoked Potential (MEP) Peak-to Peak Amplitude
timeFrame: Baseline and after the 12-week intervention.
measure: Motor Evoked Potential (MEP) Peak-to Peak Duration
timeFrame: Baseline and after the 12-week intervention.
measure: Motor Evoked Potential (MEP) Area
timeFrame: Baseline and after the 12-week intervention.
measure: Cortical Silent Period
timeFrame: Baseline and after the 12-week intervention.
measure: Voluntary Electromyography (EMG)
timeFrame: Baseline and after the 12-week intervention.
measure: Amplitude of the Sleep-Wake Cycle
timeFrame: Baseline and after the 12-week intervention.
measure: Peak Time of the sleep-wake Cycle
timeFrame: Baseline and after the 12-week intervention.
measure: Mesor of the Sleep-Wake Cycle
timeFrame: Baseline and after the 12-week intervention.
measure: inter-daily stability
timeFrame: Baseline and after the 12-week intervention.
measure: intra-daily variability
timeFrame: Baseline and after the 12-week intervention.
measure: L5
timeFrame: Baseline and after the 12-week intervention.
measure: L5 mid
timeFrame: Baseline and after the 12-week intervention.
measure: Wake actigraphy
timeFrame: Baseline and after the 12-week intervention.
measure: Sleep Activity
timeFrame: Baseline and after the 12-week intervention.
measure: Activity Index
timeFrame: Baseline and after the 12-week intervention.
measure: Time in bed
timeFrame: Baseline and after the 12-week intervention.
measure: Actual Sleep Time
timeFrame: Baseline and after the 12-week intervention.
measure: Actual Wake Time
timeFrame: Baseline and after the 12-week intervention.
measure: Sleep Onset Latency
timeFrame: Baseline and after the 12-week intervention.
measure: Sleep Efficiency
timeFrame: Baseline and after the 12-week intervention.
measure: Fragmentation index
timeFrame: Baseline and after the 12-week intervention.
measure: Blood Biomarkers
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in the Centre for Epidemiological Studies Depression Scale (CES-D) questionnaire.
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in The Social Prevision Scale (SPS)
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in The Functional Assessment of Cancer Therapy (FACT) Cancer Specific
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in The Modified-Godin Leisure Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline, after the 12-week intervention, and during follow up (6 and 12 months).
measure: Assessment of change in The Insomnia Severity Index (ISI)
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in The Brief Pain Inventory Short Form (BPI-sf)
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in Maximal Oxygen Uptake
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in Muscle Cross-Sectional Area
timeFrame: Baseline and after the 12-week intervention.
measure: Heart Rate Variability
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in Fat Mass
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in Fat Free Mass
timeFrame: Baseline and after the 12-week intervention.
measure: Assessment of change in Bone Mineral Density
timeFrame: Baseline and after the 12-week intervention.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Guillaume Millet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Twomey R, Martin T, Temesi J, Culos-Reed SN, Millet GY. Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial. BMC Cancer. 2018 Jul 24;18(1):757. doi: 10.1186/s12885-018-4668-z.