Exercise program to prevent nerve damage from chemotherapy in breast cancer patients
Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
This study is testing if a special exercise program can help prevent nerve damage in breast cancer patients receiving chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Universidad de Granada Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Granada) |
| Trial ID | NCT04652609 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if a therapeutic exercise program combined with blood flow restriction (BFR) can prevent chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing neoadjuvant chemotherapy for HER2+ breast cancer. Participants will engage in the PRESIONA exercise program, which is designed to protect nerve fibers from the neurotoxic effects of chemotherapy. The study compares the outcomes of this exercise intervention against usual care to assess its effectiveness in preventing CIPN.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a HER2+ breast cancer diagnosis who are awaiting taxanes-based neoadjuvant chemotherapy.
Not a fit: Patients with previous cancer diagnoses, those who are pregnant, or individuals with certain cardiac conditions or other neuropathy-related symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of nerve damage caused by chemotherapy in breast cancer patients.
How similar studies have performed: While there have been various approaches to prevent CIPN, the specific combination of therapeutic exercise with BFR is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * HER2+ breast cancer diagnosis * On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy) Exclusion Criteria: * Previous diagnosis of cancer * Pregnant * Cardiac pathology * No symptoms or pathology that could be confused with neuropathy or related to diabetes * No recommendation from oncologist for therapeutic exercise practice
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.