Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases

Launched by UNIVERSIDAD DE GRANADA · Feb 15, 2022

Keywords

ClinConnect Summary

This clinical trial, called the Overcome program, is designed to help women with breast cancer who have developed bone metastases, which means the cancer has spread to their bones. The goal of the study is to see if a special program of therapeutic exercise and motor control recovery can improve their physical abilities and overall quality of life. Participants will be compared to those receiving standard treatment, and their progress will be measured before the program starts and again after six months to see how well the program works.

To join the study, women must have controlled breast cancer with bone metastases, not have exercised regularly in the last three months, and be in good overall health. Participants can expect to work with a team of physiotherapists and occupational therapists who will guide them through the exercise program. This study aims to show that improving physical function can make a positive difference in the lives of women facing the challenges of metastatic breast cancer.

Gender

FEMALE

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.