Cachexia-Anorexia Syndrome Clinical Trial
Official title:
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
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.
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: Patients can join the program spontaneously or after receiving information at the hospital. At the hospital, patients diagnosed with cancer cachexia will undergo eligibility screening by clinicians within the Digestive Tract Diseases department of Rennes University Hospital (CHU Rennes, France). Clinicians will identify suitable participants and refer them to the sports-medical center SPORMED (Rennes, France), located outside the hospital, where the sessions will take place. A practice setting outside the hospital can encourage engagement and enable the study of the effects of exercise by being as close as possible to people's real-life conditions. The physiotherapist at the sports-medical center will provide participants with information about the possibility and benefits of exercise. Additionally, the physiotherapist will guide patients to the sports-medical center SPORMED (Rennes, France), where the sessions will take place. Patients enrolled in the exercise program will then receive both oral and written information about the trial. All participants will be required to sign and provide an informed consent form. Intervention : 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. Patients will have the flexibility to choose their session time between 11:30 a.m. and 4 p.m and each session will last 1 hour under the supervision of physiotherapists. The program will include both aerobic and resistance exercises. The program will adhere to the principle of "autoregulation," allowing for a reduction in exercise intensity and/or duration when treatment-related side effects will be heightened. Patients will be encouraged to maintain the prescribed exercise intensity and duration if treatment-related side effects will be manageable. 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"). Session intensity will be determined based on the HRR, which will be calculated with the theoretical maximal heart rate (HR maximal) and resting heart rate (HR rest) of the patient, with adjustments made according to the patient's feedback and treatment-related side effects. Subsequently, resistance training will begin with a mobility warm-up, followed by exercises involving body weight, free weight, elastics, swissball, etc. The protocol for resistance training is described in the Supplemental Material. Patients will perform 2 to 4 sets per exercise and 8 to 14 repetitions. Outcomes will be assessed at baseline (at the initiation of the program), post-intervention (at the end of the program), and at 3, 6, and 12 months of follow-up. All assessments will be conducted by an exercise physiologist. Demographics and treatment and diagnosis characteristics were collected at baseline during a short interview. ;