12-week physical activity program for women with early-stage hormone receptor–positive breast cancer
Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
Centro di Riferimento Oncologico - Aviano · NCT07539038
This project will try whether a 12-week physical activity program improves quality of life for women with early-stage hormone receptor–positive breast cancer who are on adjuvant endocrine therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centro di Riferimento Oncologico - Aviano (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT07539038 on ClinicalTrials.gov |
What this trial studies
This prospective observational study enrolls women with early-stage (I–IIIa) hormone receptor–positive breast cancer receiving adjuvant endocrine therapy who agree to join a 12-week physical activity program run by ANDOS onlus. Participants receive baseline and follow-up assessments of quality of life and related health measures while participating in the organized exercise program. The study does not randomize interventions but records outcomes associated with real-world program participation. Collected data will be analyzed to describe changes in quality of life and other physical health indicators over the 12-week period.
Who should consider this trial
Good fit: Women aged 18 or older with early-stage (I–IIIa) hormone receptor–positive breast cancer who are on adjuvant endocrine therapy, can provide informed consent, and can participate in the ANDOS 12-week physical activity program are ideal candidates.
Not a fit: Patients with metastatic disease, hormone receptor–negative tumors, those currently receiving chemotherapy, those with uncontrolled cardiovascular disease, a history of vertebral or femoral fractures, or those unable to attend the ANDOS program are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could show that a structured 12-week exercise program improves quality of life and physical health for early-stage hormone receptor–positive breast cancer survivors.
How similar studies have performed: Previous randomized and observational studies in breast cancer survivors have shown that exercise programs can improve quality of life and physical functioning, so this approach builds on established evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy * Female patients ≥18 years of age * Written informed consent must be obtained before any study-related assessment is performed * Participation to the Medicina and Sport physical activity program organized by Andos Pordenone Exclusion Criteria: * Patients with early hormone receptor negative breast cancer * Patients with early hormone receptor positive breast cancer receiving chemotherapy * Patients with advanced/metastatic breast cancer. * Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias). * Patients with history of vertebral and/or femoral fractures * Patients with CVDs not optimally controlled by medical therapy
Where this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico di Aviano — Aviano, Pordenone, Italy (RECRUITING)
Study contacts
- Study coordinator: Mattia Garutti
- Email: mattia.garutti@cro.it
- Phone: 0434659092
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.
Conditions: Breast Cancer