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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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