Status:
UNKNOWN
Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
Lead Sponsor:
Universidad de Granada
Conditions:
Breast Neoplasm Female
Neoplasm Metastasis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the ...
Eligibility Criteria
Inclusion
- 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
- The bone metastasis is located only at bone level (low neurological risk).
- Not having exercised regular physical during last 3 months.
- ECOG (Eastern Cooperative Oncology Group) ≤ 1.
- \> 4 weeks from a major surgery and full recovery.
Exclusion
- 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
- Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
- Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
- Have started or changed treatment hormonal during the last 3 months at recruitment.
- Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
- Present brain metastasis.
- Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations \<160/90 regardless of whether a regimen of antihypertensive therapy or not).
- 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).
- Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05244382
Start Date
February 7 2022
End Date
June 1 2025
Last Update
November 29 2023
Active Locations (1)
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1
Faculty of Health Sciences
Granada, Spain, 18016