Colon CancerREMUSCLONNCT05099211
Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program
A study testing Muscle biopsies, Muscle Strengthening and Blood and urine samples in people with Colon Cancer and Muscle Strengthening, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Muscle Strengthening
- What is being tested?
- Muscle biopsies, Muscle Strengthening and Blood and urine samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2022to Jan 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria :
- Adult patients who are < 80 years old
- with a first diagnosis of colon cancer, regardless of TNM stage
- to undergo a scheduled excision surgery (laparoscopic colectomy or laparoscopy)
- with WHO stage < 1 to the inclusion visit
- having given their written consent
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- living close to the participating center (<50 km)
- ability to understand instructions
- Criteria for inclusion of healthy subjects :
- Adult who is < 80 years old
- matched by gender, age and BMI to a patient
- with WHO stage < 1 at visit V1
- no medical contraindications to the program
- having given written consent
Who cannot join
- Criteria for exclusion of patients and healthy subjects :
- Protected Adult
- Person not affiliated to national health insurance
- Pregnant or breastfeeding woman
- uncontrolled hypertension
- Suffers from unstable diabetes of any type
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- Suffers from heart disease. Pre-surgical VO2 test will confirm authorization.
- Affected by any condition likely to complicate the performance of physical activity (neurological, psychiatric, neuromuscular disorders, severe osteoporosis)
- Patient who received neo-adjuvant chemotherapy
- Patient-specific exclusion criteria
- Patient with rectal cancer or other evolving cancer
- Subject has had cancer in the last 5 years
- Subject with a high level of physical activity according to the IPAQ questionnaire
- Criteria for exclusion of patients and healthy subjects for biopsy:
- Person with keloidosis
- Person with bleeding disorders, and/or on anticoagulant and antiaggregant medication
- hypersensitivity to lidocaine
- SECONDARY EXCLUSION CRITERIA FOR TRAINING PATIENTS
- Patient with a WHO stage > 1 at the V2 visit
- Presence of an ostomy (complicates PA practice)
- absence of post-operative chemotherapy treatment
- Refusal of the surgeon and/or oncologist and/or rehabilitation physician to practice PA SECONDARY EXCLUSION CRITERIA FOR HEALTHY SUBJECTS
- subject with a WHO stage > 1 at the V2 visit
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Dijon Bourgogne
Dijon, 21000
Anaïs GOUTERON, 03 80 29 38 15, anais.gouteron@chu-dijon.fr
Vanessa COTTET, 03 80 39 34 87, vanessa.cottet@u-bourgogne.fr
About this study
Official title: Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life.
Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it.
Read more
Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass.
Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.
- Conditions
- Colon Cancer, Muscle Strengthening
- Being tested
- Muscle biopsies, Muscle Strengthening, Blood and urine samples, Aerobic Training, Evaluation 1 pre-surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsiesProcedure or surgery
Optional
In pre-training:
Biopsy performed during the digestive surgery procedure
Final evaluation (minimum 1 day and maximum 7 days after the last training session): biopsy performed in the digestive surgery department.
Muscle StrengtheningOther
3 sessions per week for 18 weeks. Duration: 1 hour Training on different strength training machines for the main muscle groups of the lower and upper limbs. The training load will be gradually increased over the sessions.
Blood and urine samplesBiological
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
Aerobic TrainingOther
3 sessions per week for 18 weeks. Duration: 1 hour Training on a "classic" pedal bicycle (called an ergocycle). The intensity and duration of the training will be gradually increased over the sessions and according to the patient's abilities.
Evaluation 1 pre-surgeryOther
Carried out at least 15 days before surgery
- st visit:
- Nutritional assessment
- Body composition
- Psychometric tests of quality of life + IPAQ Test
- VO2pic
- nd visit:
- Neuromuscular tests
- Functional tests
Evaluation 2 post-surgeryOther
- st visit:
- Body composition
- Nutritional assessment
- Psychometric tests of quality of life
- nd visit:
- neuromuscular tests
- Functional tests
- Familiarization with training equipment if patient participates in re-training
Intermediate Evaluation 3Other
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
Final post-training evaluation 4Other
Tests identical to evaluation 1 + TM6
| Study group | Role | What they receive |
|---|---|---|
| Patients muscle strengthening | Experimental | Not described Receives: Procedure: Muscle biopsies; Other: Muscle Strengthening; Biological: Blood and urine samples; Other: Evaluation 1 pre-surgery; Other: Evaluation 2 post-surgery; Other: Intermediate Evaluation 3; Other: Final post-training evaluation 4 |
| Aerobic Training Patients | Experimental | Not described Receives: Procedure: Muscle biopsies; Biological: Blood and urine samples; Other: Aerobic Training; Other: Evaluation 1 pre-surgery; Other: Evaluation 2 post-surgery; Other: Intermediate Evaluation 3; Other: Final post-training evaluation 4 |
| Healthy patients | Active comparator | Not described Receives: Biological: Blood and urine samples; Other: Evaluation 1 pre-surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the program in terms of the number of sessions attended
Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability
Measured: Up to Week 30 (evaluation 4) for patients
Acceptability of the program in terms of the number of sessions attended
Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability
Measured: Up to Week 1 (evaluation 1) for healthy patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study startJul 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099211
- Sponsor's protocol ID
- COTTET CHU Dijon 2018
- Acronym
- REMUSCLON
- Status last verified
- Jun 2022
- First submitted
- 12 Oct 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program
- ClinicalTrials.gov ID
- NCT05099211
- Acronym / sponsor ID
- REMUSCLON / COTTET CHU Dijon 2018
- Conditions
- Colon Cancer, Muscle Strengthening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 Oct 2021 (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.
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life.
Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it.
Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass.
Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients muscle strengthening | Experimental | Procedure: Muscle biopsies, Other: Muscle Strengthening, Biological: Blood and urine samples, Other: Evaluation 1 pre-surgery, Other: Evaluation 2 post-surgery, Other: Intermediate Evaluation 3, Other: Final post-training evaluation 4 |
| Aerobic Training Patients | Experimental | Procedure: Muscle biopsies, Biological: Blood and urine samples, Other: Aerobic Training, Other: Evaluation 1 pre-surgery, Other: Evaluation 2 post-surgery, Other: Intermediate Evaluation 3, Other: Final post-training evaluation 4 |
| Healthy patients | Active comparator | Biological: Blood and urine samples, Other: Evaluation 1 pre-surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient Inclusion Criteria :
- Adult patients who are < 80 years old
- with a first diagnosis of colon cancer, regardless of TNM stage
- to undergo a scheduled excision surgery (laparoscopic colectomy or laparoscopy)
- with WHO stage < 1 to the inclusion visit
Key exclusion criteria (23 listed)
- Criteria for exclusion of patients and healthy subjects :
- Protected Adult
- Person not affiliated to national health insurance
- Pregnant or breastfeeding woman
- uncontrolled hypertension
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 |
|---|---|---|
| Muscle biopsiesOptional In pre-training: Biopsy performed during the digestive surgery procedure Final evaluation (minimum 1 day and maximum 7 days after the last training session): biopsy performed in the digestive surgery department. | Procedure or surgery | Aerobic Training Patients, Patients muscle strengthening |
| Muscle Strengthening3 sessions per week for 18 weeks. Duration: 1 hour Training on different strength training machines for the main muscle groups of the lower and upper limbs. The training load will be gradually increased over the sessions. | Other | Patients muscle strengthening |
| Blood and urine samplesfasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls | Biological | Aerobic Training Patients, Healthy patients, Patients muscle strengthening |
| Aerobic Training3 sessions per week for 18 weeks. Duration: 1 hour Training on a "classic" pedal bicycle (called an ergocycle). The intensity and duration of the training will be gradually increased over the sessions and according to the patient's abilities. | Other | Aerobic Training Patients |
| Evaluation 1 pre-surgeryCarried out at least 15 days before surgery 1. st visit: * Nutritional assessment * Body composition * Psychometric tests of quality of life + IPAQ Test * VO2pic 2. nd visit: * Neuromuscular tests * Functional tests | Other | Aerobic Training Patients, Healthy patients, Patients muscle strengthening |
| Evaluation 2 post-surgery1. st visit: * Body composition * Nutritional assessment * Psychometric tests of quality of life 2. nd visit: * neuromuscular tests * Functional tests * Familiarization with training equipment if patient participates in re-training | Other | Aerobic Training Patients, Patients muscle strengthening |
| Intermediate Evaluation 3performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6 | Other | Aerobic Training Patients, Patients muscle strengthening |
| Final post-training evaluation 4Tests identical to evaluation 1 + TM6 | Other | Aerobic Training Patients, Patients muscle strengthening |
Primary outcome
Acceptability of the program in terms of the number of sessions attended
Time frame: Up to Week 30 (evaluation 4) for patients
Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability
Acceptability of the program in terms of the number of sessions attended
Time frame: Up to Week 1 (evaluation 1) for healthy patients
Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle biopsies, Muscle Strengthening and Blood and urine samples in people with Colon Cancer and Muscle Strengthening, run by Centre Hospitalier Universitaire Dijon 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 14 inclusion and 23 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 Jun 2022. 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?
Contact Anaïs GOUTERON (03 80 29 38 15, anais.gouteron@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the program in terms of the number of sessions attended (time frame: Up to Week 30 (evaluation 4) for patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2022.