Clinical trial · Interventional
Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery is associated with better outcomes in early stage breast cancer compared to surgery alone. Fatigue is one of the most important side effects of RT because it can decrease patients' quality of life. Studies found that physical activity (PA) may help to improve quality of life in cancer survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical inactivity over a long period of time may lead to rapid energy and physical function loss. PA intervention studies in patients undergoing RT have included mostly White patients. There is no evidence on African American patients undergoing RT. The purpose of this study is to examine the efficacy of a structured, moderate-intensity, aerobic exercise program in reducing cancer-related fatigue in African Americans undergoing RT for localized breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Activity | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Physical activity
- description
- An 8-week structured, moderate-intensity aerobic training exercise regimen concurrent with their radiation therapy (N=15),
- interventionNames
- Other: Physical Activity
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients will continue with usual care, which includes radiation treatment.
Primary outcomes (1)
- measure
- Reduce cancer-related fatigue
- timeFrame
- 8 weeks
- description
- Fatigue Cancer-related fatigue will be determined using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey instrument. The FACIT-Fatigue 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. Thus, the total score ranges from 0 to 52. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * -over 18 years old or less than 75 years old. * histologically confirmed carcinoma of the breast * radiation therapy naive * sedentary, as defined as \<60 minutes of recreation or work requiring modest PA/week based on the 7 day physical activity recall questionnaire * ambulatory * negative serum pregnancy test and not planning to be pregnant in the next 3 months * ability to understand and the willingness to sign a written informed consent. * have breast cancer stage 0-IIIA * completed neo-adjuvant or adjuvant chemotherapy may be concurrently receiving endocrine or HER2 directed therapy Exclusion Criteria: * age less than 18 years old or more than 75 years * no histological confirmation of breast cancer * prior breast, chest or pelvic radiotherapy * concurrent chemotherapy * distant metastases * physical limitations (e.g., orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking program * a positive pregnancy test, currently pregnant or planning to become pregnant in the next three months * identified as the active or maintenance stage of exercise behavior * psychiatric disorder which would render the subject unable to provide informed consent.
References
Publications (0)
Data not yet available