Exercise program to reduce cancer treatment side effects in breast cancer patients
Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer
This study is testing if a special exercise program before cancer treatment can help women with breast cancer feel better and have fewer heart problems during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Universidad de Granada Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Granada) |
| Trial ID | NCT03787966 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether a tailored physical exercise program conducted before anticancer treatment can reduce the onset and severity of cardiotoxicity compared to exercise performed during treatment. It will assess the feasibility and effectiveness of this program in women diagnosed with breast cancer stages I-III, focusing on clinical and biological outcomes as well as disease-free survival. The study will be conducted in three phases with a total of 110 participants, including a pilot study and a randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of breast cancer stages I-III who are awaiting anticancer treatment.
Not a fit: Patients who have previously undergone cancer treatments or those with conditions that prevent them from exercising may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the side effects of cancer treatments, improving the quality of life for patients.
How similar studies have performed: Other studies have shown promising results in using exercise to mitigate cancer treatment side effects, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Breast cancer diagnosis I-III stage * On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy. * If they meet other criteria which predisposes to higher toxicity. * Have signed informed consent. * Have medical clearance for participation. Exclusion Criteria: * Patient underwent previous cancer treatments. * Patients were previously diagnosed with cancer. * Pregnant patients. * Patients performing other type of therapeutic exercise at diagnosis time with an intake \>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day. * Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \>70%, metastasis etc.).
Where this trial is running
Granada
- University of Granada — Granada, Spain (Recruiting)
Study contacts
- Principal investigator: Irene Cantarero-Villanueva, PhD — Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
- Study coordinator: Irene Cantarero-Villanueva, PhD
- Email: irenecantarero@ugr.es
- Phone: 958248764
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.