Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
NCT ID: NCT02846389
Last Updated: 2025-07-23
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-06-21
Study Completion Date
2017-12-03
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.
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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.
Conditions
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Cancer Related Fatigue
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Moderate Exercise
Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).
Group Type
EXPERIMENTAL
Moderate Exercise
Intervention Type
OTHER
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.
Control Group
No exercise
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Moderate Exercise
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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. women between the ages of 18 and 75 years
2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
3. radiation therapy naïve
4. 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
5. ambulatory
6. negative serum pregnancy test and not planning to become pregnant in the next three months
7. able to provide meaningful consent.
8. 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.
2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
3. radiation therapy naïve
4. 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
5. ambulatory
6. negative serum pregnancy test and not planning to become pregnant in the next three months
7. able to provide meaningful consent.
8. 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
1. younger than 18 or older than 75 years
2. no histological confirmation of breast cancer
3. prior breast, chest, or pelvic radiotherapy
4. concurrent chemotherapy
5. distant metastases
6. physical limitations that contraindicate participation in low to moderate intensity exercise
7. positive pregnancy test
8. currently engaged in moderate to vigorous physical activity
9. psychiatric disorder which would render the participant unable to provide informed consent.
2. no histological confirmation of breast cancer
3. prior breast, chest, or pelvic radiotherapy
4. concurrent chemotherapy
5. distant metastases
6. physical limitations that contraindicate participation in low to moderate intensity exercise
7. positive pregnancy test
8. currently engaged in moderate to vigorous physical activity
9. psychiatric disorder which would render the participant unable to provide informed consent.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Lombardi Comprehensive Cancer Center
OTHER
Sponsor Role
collaborator
Hackensack Meridian Health
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Brett Lewis, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hackensack UMC
Locations
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Hackensack University Medical Center
Hackensack, New Jersey, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro2016-0162
Identifier Type: -
Identifier Source: org_study_id
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