Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program

Colon Cancer Clinical Trial

— REMUSCLON  

Official title:

Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05099211
• Other study ID #: COTTET CHU Dijon 2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: January 2025

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Anaïs GOUTERON
• Phone: 03 80 29 38 15
• Email: anais.gouteron[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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 Exclusion criteria specific to healthy subjects
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• Muscle biopsies
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.

Other:
• Muscle Strengthening
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.

Biological:
• Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls

Other:
• Aerobic Training
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-surgery
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-surgery
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 3
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
• Final post-training evaluation 4
Tests identical to evaluation 1 + TM6

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to Week 30 (evaluation 4) for patients
Primary	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	Up to Week 1 (evaluation 1) for healthy patients