Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Supervised Program and One-year Follow-up of Patients and Cachexia-related Symptoms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms.
Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention.
详细描述
Study objectives and design:
The 2CAPA study will aim to assess the efficacy of a supervised 12-week APA program on cachexia symptoms; HRQoL (global QoL, fatigue, physical functioning, appetite, and pain), cancer-related fatigue, appetite, body composition (weight, lean mass, fat mass), appetite, physical condition (endurance, strength, balance), and physical activity and sedentary levels. The secondary aim will be to assess the compliance to exercise program and barriers that could affect compliance, and to explore how compliance may impact the magnitude of the observed effects. The third objective will be to determine the maintenance of physical activity levels and the effects of exercise for 1 year follow-up (at the 3-months, 6-months and 12-mon
ths follow-ups assessments) on cachexia symptoms. In summary, this study aims to assess the effectiveness of a 12-week exercise program on various parameters affected by cancer-related cachexia and identify barriers to regular participation to exercise program. Patient behavior and outcomes will then be assessed during a one-year post-program follow-up.
The 2CAPA study is a prospective, single-arm study conducted in a sport and medicine center. The study is promoted by the University of Rennes 2 (Rennes, France).
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Diagnosis of cancer cachexia according to Martin's classification
- •Undergoing treatment or within 1 year post-treatment (of any type), with or without metastasis
- •Eastern Cooperative Oncology Group Performance status ≤ 2, 5) life expectancy ≥ 3 months
- •Willingness to actively participate throughout the study
- •Ability to engage in supervised exercise program as certified by their oncologist
- •Valid health insurance affiliation,
- •Proficiency in reading, writing, and understanding French.
排除标准
- •Exhibit central nervous system involvement with neurological deficits restricting walking
- •Are concurrently participating in another exercise intervention study,
- •Are pregnant
- •Are under legal or administrative detention/ deprived of liberty by judicial or administrative decision.
研究组 & 干预措施
Exercise intervention
The exercise intervention will consist of a personalized and supervised program lasting 12 weeks with two sessions per week, held on Tuesdays and Thursdays at the Sports and Medicine Center SPORMED in Rennes, France.
Each session will combine endurance and resistance training, commencing with a 6-minute cardiovascular warm-up on ergometers (cycling ergometer or treadmill). This will be followed by 20 minutes at moderate intensity (60-70% of Heart Rate Reserve (HRR)), concluding with a 2-minute recovery period at light intensity. Heart rate will be monitored using a pulse oximeter. Participants will report their rate of perceived exertion during endurance training using a 5-point scale ("very easy," "easy," "moderate," "difficult," "very difficult").
干预措施: Exercise Intervention (Other)
结局指标
主要结局
Health-Related Quality of Life
时间窗: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Health-Related Quality of Life: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) version 3.0 will be used to assess changes in levels of health-related Quality of Life (QOL). The EORTC QLQ-C30 is an internationally validated, concise, self-reporting cancer-specific measure of health-related QOL (25). This scale comprises 30 items, including one global health status/QOL scale and five multi-item functional scales evaluating physical, role, emotional, cognitive, and social function. Additionally, three multi-item symptom scales assess fatigue, pain, and nausea/vomiting, and six single items assess symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. A high score for the global health status and QoL and for the functional scales represents a high level of QoL and functioning. Nevertheless, a high score for a symptom scale / item represents a high level of symptomatology.
次要结局
- Static balance ability(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Lean mass(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Aerobic fitness(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Appetite(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Exercise beliefs(At baseline and at 12 weeks)
- Body weight(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Muscular strength of the lower limbs(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Handgrip strength(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Stages of change for exercise(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Cancer-related Fatigue(At baseline and at 12 weeks)
- Physical Activity and Sedentary Levels(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Body mass index(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
- Fat mass(Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks)
研究者
Peyrachon Romane
Investigator, PhD
University of Rennes 2