Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

Study Overview
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Brief Summary
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Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.

Detailed Description
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Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among breast cancer patients. Eighty women with breast cancer scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life (QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.

Official Title
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Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer

Conditions
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Cancer Related Fatigue

Intervention / Treatment
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* Other: Moderate Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women between the ages of 18 and 75 years histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive) radiation therapy naïve sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire ambulatory negative serum pregnancy test and not planning to become pregnant in the next three months able to provide meaningful consent. Patients must have been deemed by their medical oncologist or internist that they may participate in [this] exercise trial. Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program. Exclusion Criteria: younger than 18 or older than 75 years no histological confirmation of breast cancer prior breast, chest, or pelvic radiotherapy concurrent chemotherapy distant metastases physical limitations that contraindicate participation in low to moderate intensity exercise positive pregnancy test currently engaged in moderate to vigorous physical activity psychiatric disorder which would render the participant unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Exercise<br>Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week). | Other: Moderate Exercise<br>* Aerobic training utilizing the portable stationary pedal exerciser (Pedlar) which contains two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. Participants are required to perform 15 minutes/day of aerobic exercise using the Pedlar device on radiation treatment days; during a standard radiation course, this will typically yield 75 minutes/week of aerobic time.<br>|
| No Intervention: Control Group<br>No exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change in fatigue via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) survey instrument. | The FACIT is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 4-point likert scale, with score ranging from 0 to 52. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability. | Baseline, 4 weeks into RT, 4 week follow up visit | 
| Assessment of change in blood biomarker of inflammation: High sensitivity CRP (hsCRP) | Serum hsCRP will be measured on the Vitros 5,1 FS Chemistry platform via an immunoassay with a reportable range of 0.10 -15.00 mg/L, and intra- and inter-assay CVs of 1.8-4.0%. | Baseline, 4 weeks into RT, 4 week follow up visit | 
| Assessment of change in blood biomarker of inflammation: Serum fibrinogen | Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%. | Baseline, 4 weeks into RT, 4 week follow up visit | 
| Assessment of change in blood biomarker of inflammation: Ferritin | Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%. | Baseline, 4 weeks into RT, 4 week follow up visit | 
| Complete blood count data (CBC) | We will collect CBC data at each blood draw for correlative and explorative purposes. | Baseline, 4 weeks into RT, 4 week follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires. | The HRQOL measures four different domains (physical well-being, functional well-being, emotional well-being, and social/family well-being). FACT-B is a breast cancer specific module that will be used to reflect patients' concerns; moreover, they are reliable, reproducible, and have been validated in numerous studies. | Baseline, 4 weeks into RT, 4 week follow up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation therapy for Breast Cancer