Therapeutic exercise program to prevent neurotoxicity in breast cancer patients
Neurotoxicity Prevention With a Multimodal Program (ATENTO) Prior to Cancer Treatment Versus Throughout Cancer Treatment in Women Newly Diagnosed for Breast Cancer: a Randomized Clinical Trial.
This study is testing a special exercise program to see if it can help women newly diagnosed with breast cancer avoid nerve damage from their treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada) |
| Trial ID | NCT04583124 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a multimodal intervention combining therapeutic exercise and vagal activation techniques in preventing neurotoxicity in women newly diagnosed with breast cancer. The intervention will be tested in two groups: one receiving the program before starting potentially neurotoxic treatments and another during the treatments. The study will involve 56 participants and will assess the impact of this approach on the quality of life and neurotoxicity outcomes. The goal is to provide evidence for early intervention methods that could mitigate the adverse effects of cancer treatments.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of Stage I-III breast cancer awaiting adjuvant treatment that poses a risk of neurotoxicity.
Not a fit: Patients with a history of cancer treatment, pregnant individuals, or those with neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for breast cancer patients by reducing neurotoxicity associated with their treatments.
How similar studies have performed: While the specific combination of therapeutic exercise and vagal activation techniques is novel, similar interventions have shown promise in improving quality of life and reducing side effects in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * To have 18 years or older * To have a breast cancer diagnosis (Stage I-III) * To be on waiting list for medical adjuvant treatment with risk of central and/or peripheral neurotoxicity. * To have signed the informed consent. * To have medical clearance for participation. Exclusion Criteria: * To have a previous history of cancer or any cancer treatment. * Pregnant patients. * To participate in another intervention that could influence on the outcomes. * To have a neurodegenerative disease that affects central or peripheral nervous system and could influence the results.
Where this trial is running
Granada
- University of Granada — Granada, Spain (Recruiting)
Study contacts
- 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.