Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 313
- 试验地点
- 17
- 主要终点
- Health-related quality of life (HRQoL) at 16 weeks
研究概览
简要总结
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.
Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population
详细描述
The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.
The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.
200 randomized patients are required.
The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).
Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Histologically proven non resectable pancreatic adenocarcinoma
- •Indication of palliative chemotherapy
- •Life expectancy ≥ 3 months
- •Eastern Cooperative oncology group (ECOG) - Performance status ≤2
- •Age ≥18 years old
- •At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance Imaging)
- •Identified Accompanying partner Adapted Physical Activity (AAPA)
- •Signed and dated informed consent
- •Registration in a National Health Care System (CMU included for France)
排除标准
- •Previous Cerebrovascular accident or myocardial infarction <6months
- •Uncontrolled hypertension.
- •Severe cardiovascular or respiratory disease
- •Severe cognitive or psychiatric disorder
- •Severe motor and/or sensory neuropathy
- •Rheumatologic or orthopedic problem or bone lesions with a fracture risk
- •Others comorbidities contra-indicated physical exercises
- •Patient protected by the law - Guardianship and trusteeship
结局指标
主要结局
Health-related quality of life (HRQoL) at 16 weeks
时间窗: At 16 weeks
HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.
次要结局
- MFI-20 and EORTC QLQ C-30 evaluation(at 6, 12 et 24 months)
- General state - Performance status OMS(up to 24 months)
- medico-economic evaluation(up to 24 months)
- Time To deterioration (TTD)(Up to 24 months)
- Brief Pain Inventory Short form questionnaire(Up to 24 months)
- Nutritional status evaluation(up to 24 months)
- Physical Activity evaluation - IPAQ questionnaire(up to 24 months)
- Progression free survival (PFS)(2 years)
- Patient depression scale - HADS questionnaire(Up to 24 months)
- Accompanying partner depression scale (HADS questionnaire)(up to 24 months)
- Number of Adverse events (AE) grade 3 -4(up to 24 months)
- analgesic consumption(up to 24 months)
- Overall Survival (OS)(2 years)
- Fatigue scale (EVA fatigue)(up to 24 months)
- visual analog scale for pain(up to 24 months)
- anxiolytic / antidepressant consumption(up to 24 months)