Impact of Exercise on Fatigue in Breast Cancer Patients During Chemotherapy
Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy
This study is testing whether a home-based exercise program can help women with breast cancer feel less tired while they are undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Virtua Health, Inc. Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Voorhees Township, New Jersey) |
| Trial ID | NCT05704842 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a home-based exercise program aimed at reducing cancer-related fatigue in women undergoing chemotherapy for breast cancer. Participants are randomly assigned to either an exercise intervention group or a control group with no exercise. Patient-reported outcomes are collected using the FACIT Fatigue Scale and the PRO-CTCAE tool, with assessments conducted weekly during chemotherapy and at follow-up intervals. The study aims to assess recruitment, retention, and adherence to the exercise regimen, as well as changes in fatigue levels over time.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with curative-intent breast cancer planning to undergo at least 4 cycles of chemotherapy.
Not a fit: Patients with severe psychiatric disorders, contraindications to exercise, or those not cleared by a cardiologist may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce fatigue in breast cancer patients undergoing chemotherapy, improving their quality of life.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer patients, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy. * Age \> 18 years * ECOG performance score \< 3 * English-speaking * with sufficient vision/hearing or family support * Coronary artery disease, if cleared by cardiologist * Subject must have smart phone, computer or tablet. * Willingness to be randomized Exclusion Criteria: * Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions). * Patients with overt evidence of a psychiatric disorder. * Coronary artery disease, not cleared by cardiologist. * Contraindication to exercise. * Chronic fatigue syndrome.
Where this trial is running
Voorhees Township, New Jersey
- Virtua Health — Voorhees Township, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Priya P Gor, MD, MSCE — Penn Medicine
- Study coordinator: Susan VanLoon, RN, CCRP
- Email: svanloon@virtua.org
- Phone: 8562477382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.