An interventional study of Exercise Intervention in Cachexia-Anorexia Syndrome, sponsored by Peyrachon Romane. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Peyrachon Romane · Not applicable, Interventional, and Supportive care
Among 15 studies in Cachexia with a site in France — 4 open to participants now, 4 under way, 2 of them phase 3. Cachexia · France.
Among the 15 studies in Cachexia with a site in France, this one is the only one that started in 2024, is one of 4 with no phase, and was the 12th registered.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
Browse Cachexia studies →4 of the 15 studies in Cachexia with a site in France are open now. Recruiting first, the newest first:
CatalYm GmbH · Sites in France, United States, Bulgaria and 11 more countries
Pfizer · Sites in France, United States, Australia and 18 more countries
University Hospital, Tours · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 56 Cachexia studies recruiting now, 32 (57%) set no upper age limit and 15 (27%) stop at 75 or younger; 8 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 5
First in 2008; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 31 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Median enrollment 59 across the 9 interventional studies, 102 across the 6 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 15 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Peyrachon Romane as lead sponsor.
Peyrachon Romane has 1 study filed under Cachexia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Cachexia with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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").
Other: 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 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
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.
Time frame: Through study completion : Baseline, 12 weeks, 24 weeks, 36 weeks, 60 weeks
Body weight
Body weight (in kilograms) will be measured by bioelectrical impedance analysis (Tanita, DC-360).
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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")
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: At baseline and at 12 weeks
Compliance to exercise intervention
The overall compliance rate will be calculated as the number of completed exercise sessions/total prescribed sessions.
Time frame: During the 12-week program
Reasons for absence
Reasons for missed sessions will be collected from the participant by phone or at their next session. Reasons will be categorized into medical reasons, personal reasons, environmental reasons, and professional reasons.
Time frame: During the 12-week program
Timing of absences
The timing of absences will also be recorded and studied. The timing of absences will be expressed in the form start of program, middle of program, end of program
Time frame: During the 12-week program
Fidelity to session duration
Fidelity rates will be determined by comparing the prescribed duration of session versus actual exercise duration (in minutes)
Time frame: During the 12-week program
Fidelity to session intensity
Intensity fidelity rates will be determined by comparing the prescribed intensity versus actual exercise intensity (expressed in percentage of Heart-Rate Reserve and self-perception of effort).
Time frame: During the 12-week program
Reasons to modify exercise sessions
The occurrence and reasons for adjustments in aerobic exercise intensity will be recorded by a physiotherapist.
Time frame: During the 12-week program
Incidence of Adverse Events
Physiotherapists will monitor and record serious adverse events and program interruptions due to exercise complications.
Time frame: During the 12-week program
Plan to share: Yes — The study protocol will be published. Anonymized patient data and statistical analyses will be available.
Supporting information: Study protocol, Informed consent form
Time frame: Information will be available in 2024 for an infinite duration.
Access criteria: Open access
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jan 2026, 24 months after the start.
Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 24 months is above that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.