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

University Hospital Center (CHU) Dijon Bourgogne

Status: Not yet enrolling

Conditions: Colon Cancer; Muscle Strengthening

Treatments: Other: Final post-training evaluation 4; Other: Intermediate Evaluation 3; Other: Aerobic Training; Other: Evaluation 1 pre-surgery; Biological: Blood and urine samples; Other: Evaluation 2 post-surgery; Other: Muscle Strengthening; Procedure: Muscle biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT05099211

COTTET CHU Dijon 2018

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Patients muscle strengthening

Experimental group

Treatment:

Other: Evaluation 1 pre-surgery

Other: Evaluation 2 post-surgery

Biological: Blood and urine samples

Other: Muscle Strengthening

Other: Intermediate Evaluation 3

Procedure: Muscle biopsies

Other: Final post-training evaluation 4

Aerobic Training Patients

Experimental group

Treatment:

Other: Evaluation 1 pre-surgery

Other: Evaluation 2 post-surgery

Biological: Blood and urine samples

Other: Intermediate Evaluation 3

Procedure: Muscle biopsies

Other: Final post-training evaluation 4

Other: Aerobic Training

Healthy patients

Active Comparator group

Treatment:

Other: Evaluation 1 pre-surgery

Biological: Blood and urine samples