Clinical trial NCT05099211: Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: an APA Muscle Rendorcement Program
Official title: Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Muscle Strengthening
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Acceptability of the program in terms of the number of sessions attended
timeFrame: Up to Week 30 (evaluation 4) for patients
measure: Acceptability of the program in terms of the number of sessions attended
timeFrame: Up to Week 1 (evaluation 1) for healthy patients
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: