OveRCoME: functiOnal Recovery Cancer MEtastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Functional capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •> 4 weeks from a major surgery and full recovery.
排除标准
- •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.
结局指标
主要结局
Functional capacity
时间窗: Participants will be followed over 14 weeks
6-minute walking test
Quality of life (QLQ)
时间窗: Participants will be followed over 14 weeks
QLQ-C30 (Quality of Life of Cancer Patients) by the "European organization for reseach and treatment of cáncer quality life" (EORTC). This scale has 30 items, divided into a global health scale, 5 function subscales and 9 items/symptom scales. The scoring is obtained from through an Excel template.
次要结局
- Muscle architecture of multifidus muscle(Participants will be followed over 14 weeks)
- Pain threshold on pressure, by algometry(Participants will be followed over 14 weeks)
- Lower limb strength(Participants will be followed over 14 weeks)
- Body composition(Participants will be followed over 14 weeks)
- Anxiety and depression(Participants will be followed over 14 weeks)
- Specific quality of life of the patient with bone metastasis(Participants will be followed over 14 weeks)
- Opioid consumption and pain(Participants will be followed over 14 weeks)
- hand strength(Participants will be followed over 14 weeks)
研究者
Mario Lozano-Lozano
Principal investigator
Universidad de Granada