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Trial Title:
Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up.
NCT ID:
NCT06323733
Condition:
Cachexia-Anorexia Syndrome
Conditions: Official terms:
Wasting Syndrome
Anorexia
Cachexia
Conditions: Keywords:
Cachexia
Cancer
Exercise
Body composition
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
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 last 1 hour under the
supervision of physiotherapists. 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
Arm group label:
Exercise intervention
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SPORMED
Address:
City:
Rennes
Zip:
35000
Country:
France
Start date:
January 1, 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Peyrachon Romane
Agency class:
Other
Source:
University of Rennes 2
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323733