Back to results

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

Primary Purpose

Colon Cancer, Muscle Strengthening

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Muscle biopsies

Muscle Strengthening

Blood and urine samples

Aerobic Training

Evaluation 1 pre-surgery

Evaluation 2 post-surgery

Intermediate Evaluation 3

Final post-training evaluation 4

About this trial

This is an interventional prevention trial for Colon Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Chu Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Patients muscle strengthening

Aerobic Training Patients

Healthy patients

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05099211

First Posted

October 12, 2021

Last Updated

June 15, 2022

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT05099211

Brief Title

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

Acronym

REMUSCLON

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2022 (Anticipated)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer, Muscle Strengthening

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients muscle strengthening

Arm Type

Experimental

Arm Title

Aerobic Training Patients

Arm Type

Experimental

Arm Title

Healthy patients

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Muscle biopsies

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Muscle Strengthening

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Blood and urine samples

Intervention Description

fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls

Intervention Type

Other

Intervention Name(s)

Aerobic Training

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Evaluation 1 pre-surgery

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Evaluation 2 post-surgery

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Intermediate Evaluation 3

Intervention Description

performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6

Intervention Type

Other

Intervention Name(s)

Final post-training evaluation 4

Intervention Description

Tests identical to evaluation 1 + TM6

Primary Outcome Measure Information:

Title

Acceptability of the program in terms of the number of sessions attended

Description

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

Time Frame

Up to Week 30 (evaluation 4) for patients

Title

Acceptability of the program in terms of the number of sessions attended

Description

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

Time Frame

Up to Week 1 (evaluation 1) for healthy patients

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anaïs GOUTERON

Phone

03 80 29 38 15

anais.gouteron@chu-dijon.fr

Facility Information:

Facility Name

Chu Dijon Bourgogne

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anaïs GOUTERON

Phone

03 80 29 38 15

anais.gouteron@chu-dijon.fr

First Name & Middle Initial & Last Name & Degree

Vanessa COTTET

Phone

03 80 39 34 87

vanessa.cottet@u-bourgogne.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs