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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05099211
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-10-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-21
• Study Start: 2022-07
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Training Patients	Blood and urine samples	-
Patients muscle strengthening	Intermediate Evaluation 3	-
Aerobic Training Patients	Aerobic Training	-
Patients muscle strengthening	Evaluation 1 pre-surgery	-
Patients muscle strengthening	Evaluation 2 post-surgery	-
Aerobic Training Patients	Intermediate Evaluation 3	-
Healthy patients	Blood and urine samples	-
Patients muscle strengthening	Muscle Strengthening	-
Patients muscle strengthening	Blood and urine samples	-
Patients muscle strengthening	Final post-training evaluation 4	-
Aerobic Training Patients	Muscle biopsies	-
Patients muscle strengthening	Muscle biopsies	-
Aerobic Training Patients	Evaluation 1 pre-surgery	-
Aerobic Training Patients	Evaluation 2 post-surgery	-
Aerobic Training Patients	Final post-training evaluation 4	-
Healthy patients	Evaluation 1 pre-surgery	-

Primary Outcome Measures

Name	Time	Method
Acceptability of the program in terms of the number of sessions attended	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

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France