NCT03169075进行中（未招募）不适用
Study Evaluating the Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program, for Metastatic Cancer Patients Receiving Oral Targeted Therapy: The UNICANCER SdS 01 QUALIOR Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 190
- 试验地点
- 30
- 主要终点
- FACT-F relative on Fatigue
研究概览
简要总结
This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) <3/10), and life expectancy ≥3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's ≥18 years old.
- •Patient treated for a metastatic solid tumour within the following 4 cohorts: breast cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers).
- •Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
- •Patients may have been treated with immunotherapy.
- •Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
- •Life expectancy of ≥3 months.
- •ECOG performance status ≤
- •Patients able to comply with the constraints of the SPEP protocol.
- •Pain under control (VAS ˂3; 0-10 scale).
- •Haemoglobin level ≥9 g/dL.
- •Patient must have signed the informed consent form before any study-related procedures.
- •Patients must have public health insurance coverage.
排除标准
- •Patient receiving an injectable targeted therapy.
- •Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
- •Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
- •Patient with known risk of fracture, symptomatic cardiac insufficiency (NYHA-3), respiratory insufficiency (grade 3), intense pain not controlled with analgesic treatment, and/or neuropathy (grade 3).
- •Patients with a history of cancer in the last 5 years (except basal cell carcinoma adequately treated and in situ cervical cancer treated and cured).
- •Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
- •Bone metastases with risk of fractures.
- •Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
- •Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
- •Persons deprived of liberty or under guardianship.
研究组 & 干预措施
ARM A: A
Experimental
Supervised physical exercise programs (SPEP)
干预措施: Supervised physical exercise programs (Behavioral)
ARM B: B
Active Comparator
Adapted physical activity (APA)
干预措施: Adapted physical activity (Behavioral)
结局指标
主要结局
FACT-F relative on Fatigue
时间窗: Month 3 ( M3)
Self reported Questionnaires
FACT-G
时间窗: Month3 ( M3)
Self Reported Questionnaire relative on Well-Being Patient
次要结局
- Evaluation of Anorexia(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Benefit of physical activity: walk(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Physical Activity IPAQ(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Benefit of physical activity muscle function(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Quality of life(Month 1, Month 2, Month 3, and every 3 months for 1 year)
- Toxicities Secondaries effectsToxicities according NCI-CTC (National Cancer Institute Updates CTCAE to v.4.03. Common Terminology Criteria )(Baseline, Month 1, Month 2, Month 3, and every 3 months for 1 year)
- PFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 75 months)
- OS(From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 75 months)
- Pain(Month 1, Month 2, Month 3, and every 3 months for 1 year)
- Physical Activity, Body Mass Index(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Compliance about oral targeted therapy(Baseline, Month 1, Month 2, Month 3)
- Benefit of physical activity muscle strength(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Scores of anxiety and depression(Baseline, Month 1, Month 2, Month 3)
- Evaluation of Ingesta, Anorexia(Baseline, Month 3)
- Evaluation of Ingesta, VAS(Baseline, Month 3)
- Cognitive functions(Baseline, Month 1, Month 2, Month 3 and every 3 months for 1 year)
- Fatigue(Month 1, Month 2, Month 3, and every 3 months for 1 year)
研究者
研究点 (30)
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