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

June 15, 2022 updated by: Centre Hospitalier Universitaire Dijon

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy patients
Biological: Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
Other: Evaluation 1 pre-surgery

Carried 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
Experimental: Patients muscle strengthening
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: Evaluation 1 pre-surgery

Carried 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: Evaluation 2 post-surgery

  1. 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: Intermediate Evaluation 3
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
Other: Final post-training evaluation 4
Tests identical to evaluation 1 + TM6
Experimental: Aerobic Training Patients
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.

Biological: Blood and urine samples
fasting blood sample taken at assessments 1, 2, 3 and 4 for patients and assessment 1 for controls
Other: Evaluation 1 pre-surgery

Carried 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: Evaluation 2 post-surgery

  1. 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: Intermediate Evaluation 3
performed 9 weeks after the beginning of training Identical tests to evaluation 1 + TM6
Other: Final post-training evaluation 4
Tests identical to evaluation 1 + TM6
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to Week 30 (evaluation 4) for patients
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
Up to Week 1 (evaluation 1) for healthy patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COTTET CHU Dijon 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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