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Spots Global Cancer Trial Database for Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

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Trial Identification

Brief Title: Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

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

Study ID: NCT02846389

Interventions

Moderate Exercise

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Brett Lewis, M.D., Ph.D

Affiliation: Hackensack UMC

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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