Exercise interventions for breast cancer patients undergoing chemotherapy
A Feasibility Study to Examine Two Remotely-monitored Exercise Interventions on Breast Cancer Patients Undergoing Cardiotoxic Chemotherapies
This study is testing whether a high-intensity workout or a moderate walking program can help breast cancer patients feel better and stay healthier while they go through chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | Trastuzumab, Pertuzumab, Pembrolizumab, chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05786014 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of two different exercise interventions on breast cancer patients receiving cardiotoxic chemotherapy. It will compare a high-intensity interval exercise program with a moderate-intensity walking program, both monitored remotely. The interventions will begin one week prior to chemotherapy and continue throughout the treatment period, which typically lasts four months. The study will assess various cardiovascular and quality of life outcomes to determine the feasibility and effectiveness of these exercise regimens.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older diagnosed with breast cancer who are about to start specific chemotherapy regimens and have physician clearance for exercise.
Not a fit: Patients with previous exposure to cardiotoxic chemotherapy or significant comorbidities that prevent exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve cardiovascular health and quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown promise in using exercise to mitigate chemotherapy-related side effects, but the specific approach of remotely monitored exercise is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or over * diagnosis of breast cancer (Stage I-III or IV with minimal burden) and prescribed chemotherapy (TC (Docetaxel/Cyclophosphamide), AC (Doxorubicin/Cyclophosphamide followed by Paclitaxel), TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab), TCH (Docetaxel/Carboplatin/Trastuzumab) with or without Pembrolizumab) * Physician clearance for exercise training * Speak/understand English Exclusion Criteria: * previous treatment with cardiotoxic chemotherapy * medical/orthopedic comorbidities that preclude stationary cycling * significant cardiac/renal/hepatic/hematological/pulmonary disease precluding exercise training * unstable angina or myocardial infarction within 4-weeks prior to treatment * complex ventricular arrhythmias or New York Heart Association class IV symptoms * symptomatic severe aortic stenosis * acute pulmonary embolus * acute myocarditis * History of untreated high-risk proliferative retinopathy * History of retinal hemorrhage * uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg) * severe baseline electrolyte abnormalities * medication non-compliance * uncontrolled metabolic disease (diabetes with fasting blood sugar \>300 mg/dl, thyrotoxicosis, myxedema) * symptomatic peripheral vascular disease * Pregnant women
Where this trial is running
Charlottesville, Virginia
- University of Virginia University Hospital — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Siddhartha S Angadi, PhD
- Email: ssa2w@virginia.edu
- Phone: 434-243-7466
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.