Breast Cancer Clinical Trial

Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

Summary

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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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

24

Study ID:

NCT02846389

Recruitment Status:

Active, not recruiting

Sponsor:

Hackensack Meridian Health

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There is 1 Location for this study

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Hackensack University Medical Center
Hackensack New Jersey, 07601, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

24

Study ID:

NCT02846389

Recruitment Status:

Active, not recruiting

Sponsor:


Hackensack Meridian Health

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