Therapeutic exercise program for women with breast cancer and bone metastases

OveRCoME: functiOnal Recovery Cancer MEtastasis

This study tests a special exercise program to see if it can help women with breast cancer that has spread to their bones feel better and improve their daily lives compared to standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universidad de Granada (other)
• Locations: 1 site (Granada)
• Trial ID: NCT05244382 on ClinicalTrials.gov

What this trial studies

This program aims to improve the functional capacity and quality of life of women with metastatic breast cancer, specifically those with bone metastases. Participants will engage in a therapeutic exercise regimen that includes functional recovery techniques and ultrasound feedback. The effectiveness of this program will be compared to standard treatment, with evaluations conducted before and after the intervention, as well as a follow-up assessment six months later. The study will recruit patients from two hospitals in Granada who meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are women with controlled primary breast cancer and one or more bone metastases, who have not exercised regularly in the past three months.

Not a fit: Patients with significant cardiac toxicity, high neurological risk, or those who have recently changed hormonal treatment may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could enhance the functional capacity and overall quality of life for women suffering from breast cancer with bone metastases.

How similar studies have performed: While similar approaches have been explored, this specific program's methodology and focus on ultrasound feedback may offer novel insights into therapeutic exercise for this patient population.

Eligibility criteria

Inclusion Criteria:

1. Having breast cancer controlled primary and occurrence of one or more bone lesions (metastases osteoblastic) with location in the pelvis, lumbar spine and / or thoracic, attributable to breast cancer
2. The bone metastasis is located only at bone level (low neurological risk).
3. Not having exercised regular physical during last 3 months.
4. ECOG (Eastern Cooperative Oncology Group) ≤ 1.
5. \> 4 weeks from a major surgery and full recovery.

Exclusion Criteria:

1. Present cardiac toxicity secondary to treatments with decreased LVEF (If the LVEF percentage falls ≥ 10 points with respect to baseline or LVEF is below 50%) or QT prolongation
2. Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
3. Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
4. Have started or changed treatment hormonal during the last 3 months at recruitment.
5. Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
6. Present brain metastasis.
7. Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations \<160/90 regardless of whether a regimen of antihypertensive therapy or not).
8. Having had a serious cardiovascular event recently (in the last 12 months), including, but not limited to ischemic attack transient (TIA), cerebrovascular accident (CVA) or myocardial infarction (MI).
9. Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.

Where this trial is running

Granada

• Faculty of Health Sciences — Granada, Spain (RECRUITING)

Study contacts

• Study coordinator: Mario Lozano-Lozano, Dr

Conditions: Breast Neoplasm Female, Neoplasm Metastasis, Spinal Neoplasms