Clinical trial NCT06323733: Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up.
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cachexia-Anorexia Syndrome
Keywords: Cachexia
Cancer
Exercise
Body composition
Quality of life
Lead sponsor: University of Rennes 2
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Secondary outcomes:
measure: Body weight
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Body mass index
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Lean mass
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Fat mass
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Aerobic fitness
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Muscular strength of the lower limbs
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Handgrip strength
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Static balance ability
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Appetite
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Cancer-related Fatigue
timeFrame: At baseline and at 12 weeks
measure: Physical Activity and Sedentary Levels
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Stages of change for exercise
timeFrame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
measure: Exercise beliefs
timeFrame: At baseline and at 12 weeks
Other outcomes:
measure: Compliance to exercise intervention
timeFrame: During the 12-week program
measure: Reasons for absence
timeFrame: During the 12-week program
measure: Timing of absences
timeFrame: During the 12-week program
measure: Fidelity to session duration
timeFrame: During the 12-week program
measure: Fidelity to session intensity
timeFrame: During the 12-week program
measure: Reasons to modify exercise sessions
timeFrame: During the 12-week program
measure: Incidence of Adverse Events
timeFrame: During the 12-week program
Locations:
city: Rennes
country: France
facility: SPORMED
state: Bretagne
Study officials:
affiliation: Rennes 2 University, M2S lab EA7470
name: Romane Peyrachon, MhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes 2 University, M2S lab EA7470
name: Amélie Rébillard, PhD
role: STUDY_DIRECTOR
References: