Clinical trial NCT05244382: Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
Official title: OveRCoME: functiOnal Recovery Cancer MEtastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Female
Neoplasm Metastasis
Spinal Neoplasms
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 established inclusion criteria. With this study, it is pretend to demonstrate the benefits of a program of therapeutic exercise and functional recovery of motor control with ultrasound feedback for the improvement of the functional capacity of the women eligible to participate in the study, as well as a positive impact on the quality of life of the patients other than their survival. The effect of the Overcome program will be compared with the usual treatment in this type of pathology. To do this, a pre-intervention evaluation and another at the end of the evaluation of the variables to be measured, such as functional capacity, will be carried out. In addition other evaluation will be carried out, after 6 months to assess the long-term effects.

In addition to the three main variables such as functional capacity and quality of life, another relationship of secondary variables will be studied, such as physical state, body composition or pain threshold, among others. This study in its entirety will be carried out by the "Oncology Patient Support Unit - Take Care" in the hands of a multidisciplinary team, carrying out the intervention protocolized by physiotherapists and occupational therapists.


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.

Primary outcomes:
measure: Functional capacity
timeFrame: Participants will be followed over 14 weeks
measure: Quality of life (QLQ)
timeFrame: Participants will be followed over 14 weeks
Secondary outcomes:
measure: hand strength
timeFrame: Participants will be followed over 14 weeks
measure: Lower limb strength
timeFrame: Participants will be followed over 14 weeks
measure: Body composition
timeFrame: Participants will be followed over 14 weeks
measure: Muscle architecture of multifidus muscle
timeFrame: Participants will be followed over 14 weeks
measure: Pain threshold on pressure, by algometry
timeFrame: Participants will be followed over 14 weeks
measure: Anxiety and depression
timeFrame: Participants will be followed over 14 weeks
measure: Opioid consumption and pain
timeFrame: Participants will be followed over 14 weeks
measure: Specific quality of life of the patient with bone metastasis
timeFrame: Participants will be followed over 14 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
References: