Cachexia-Anorexia Syndrome2CAPANCT06323733
Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up.
A study testing Exercise Intervention in people with Cachexia-Anorexia Syndrome, run by Peyrachon Romane at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia-Anorexia Syndrome
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cachexia-Anorexia Syndrome
- Being tested
- Exercise Intervention
- Keywords
- Cachexia, Cancer, Exercise, Body composition, Quality of life
- Medical subject headings
- Cachexia, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | 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"). Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
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.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Secondary outcomes (13)
Body weight
Body weight (in kilograms) will be measured by bioelectrical impedance analysis (Tanita, DC-360).
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Body mass index
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Lean mass
Lean mass (in kilograms and expressed as a percentage of total body weight will be determined by bioelectrical impedance analysis (Tanita, DC-360).
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Fat mass
Fat mass (in kilograms and expressed as a percentage of total body weight) will be determined by bioelectrical impedance analysis (Tanita, DC-360).
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Aerobic fitness
Aerobic fitness: Participants will undergo a 6-minute walk test on a flat, indoor, 20-meter walkway.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Muscular strength of the lower limbs
Muscular strength of the lower limbs will be assessed using the sit-to-stand (30 seconds) test.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Handgrip strength
The muscular strength of the upper limbs will be assessed through a handgrip test using a hand dynamometer (Takei 5401 Hand Grip Dynamometer (digital)) and expressed in kilograms.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Static balance ability
Static balance ability will be assessed using a one-leg stand test, performances will be expressed in seconds.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Appetite
Appetite will be assessed using the SEFI (Simple Evaluation of Food Intake). SEFI is a scale that evaluates the quantity of ingesta from 1 to 10. A score of 7 or less indicates anorexia
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Cancer-related Fatigue
Fatigue will be measured using the Multidimensional Fatigue Inventory (MFI-20). The questionnaire consists of 20 statements in which the patient rate themselves on a Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree")
Measured: At baseline and at 12 weeks
Physical Activity and Sedentary Levels
Participants will recall and self-report their physical activity levels (frequency and duration of vigorous intensity, moderate intensity, walking, and sitting) during the previous 7 days, using the International Physical Activity Questionnaire Short Form (IPAQ-SF). Depending on their results, patients may be considered sedentary, inactive, moderately active or very active.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Stages of change for exercise
The stages of change for exercise will be evaluated by a scale derived from the transtheoretical model of behavior change.
Measured: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Exercise beliefs
Exercise beliefs will be assessed through the Cancer Exercise Stereotypes Scale (CESS). The questionnaire consists of 19 statements in which the patients rate themselves on a Likert scale ranging from 1 ("strongly disagree") to 6 ("strongly agree").
Measured: At baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cachexia-Anorexia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peyrachon Romane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peyrachon Romane, University of Rennes 2
- Investigators
- Romane Peyrachon, MhD, Principal investigator, Rennes 2 University, M2S lab EA7470Amélie Rébillard, PhD, Study director, Rennes 2 University, M2S lab EA7470
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323733
- Sponsor's protocol ID
- 2CAPA
- Acronym
- 2CAPA
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be published. Anonymized patient data and statistical analyses will be available.
Publications
Peyrachon R, Richard C, Gelein B, Lievre A, Andre N, Chaory K, Rebillard A. Rationale and design of an exercise intervention for patients with cancer cachexia: protocol for a one-year follow-up prospective study (2CAPA). BMC Sports Sci Med Rehabil. 2025 May 24;17(1):129. doi: 10.1186/s13102-025-01173-8.
PubMed 40413464
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06323733
- Acronym / sponsor ID
- 2CAPA / 2CAPA
- Conditions
- Cachexia-Anorexia Syndrome
- Keywords
- Cachexia, Cancer, Exercise, Body composition, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Peyrachon RomaneUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Other: Exercise InterventionThe 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"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionThe 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 | Other | Exercise intervention |
Primary outcome
Health-Related Quality of Life
Time frame: 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.
13 secondary outcomes
Body weight
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Body mass index
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Lean mass
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Fat mass
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Aerobic fitness
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Muscular strength of the lower limbs
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Handgrip strength
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Static balance ability
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Appetite
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Cancer-related Fatigue
Time frame: At baseline and at 12 weeks
Physical Activity and Sedentary Levels
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Stages of change for exercise
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Exercise beliefs
Time frame: At baseline and at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 40413464Peyrachon R, Richard C, Gelein B, Lievre A, Andre N, Chaory K, Rebillard A. Rationale and design of an exercise intervention for patients with cancer cachexia: protocol for a one-year follow-up prospective study (2CAPA). BMC Sports Sci Med Rehabil. 2025 May 24;17(1):129. doi: 10.1186/s13102-025-01173-8.
- Individual participant dataSharing planned: Yes. The study protocol will be published. Anonymized patient data and statistical analyses will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romane Peyrachon, MhD principal investigator
Rennes 2 University, M2S lab EA7470
Amélie Rébillard, PhD study director
Rennes 2 University, M2S lab EA7470
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Cachexia-Anorexia Syndrome, run by Peyrachon Romane at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06323733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.