CClinicalTrials.gg
Status unknownNCT04136249ColCanterUpdated Mar 10, 2020

Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study

An interventional study of Over physical activity in Cancer and Cachexia; Cancer, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is based on the assumption that muscle strength and muscle mass will be better preserved in an "intervention" group with specific management combining retraining and nutritional monitoring compared to the "no intervention" group and that this will be positive consequences for fatigue and quality of life. In addition, this project is also based on the assumption that these gains will be at least partially preserved 3 months after the end of specific care.

Read the detailed description

Cancer patients have a significant risk of losing muscle mass, mainly related to cachexia, as a result of metabolic changes associated with the tumor process and treatments. However, it is reinforced by the sedentary lifestyle that results from fatigue felt by patients. This loss of muscle mass causes in patients with general weakness and a loss of maximum strength. However, it has recently been shown that muscle weakness is not only a consequence of muscle atrophy, but also the result of contractile dysfunction, which reduces fatigue resistance to exercise. Cancer cachexia can also be directly associated with high levels of subjective cancer-related fatigue.

While it has been reported that resistance exercise programs can mitigate the deleterious effects of the disease and / or treatment, the results are likely to be partly debated because these programs are not optimized.

This study proposes to use eccentric contraction and electromyostimulation because there is evidence that the effects of these methods used in combination may be greater in developing strength and muscle mass.

In addition to muscle building, nutritional monitoring is a key element of recovery. For example, it has been shown that a preoperative exercise and nutritional support program has the potential to reduce sarcopenia and improve postoperative outcomes in elderly sarcopenic patients with gastric cancer.

Ultimately, this study is based on the assumption that muscle strength and muscle mass will be better preserved in an "intervention" group with specific management combining retraining and nutritional monitoring compared to the "no intervention" group and that this will be positive consequences for fatigue and quality of life. In addition, this project is also based on the assumption that these gains will be at least partially preserved 3 months after the end of specific care.

02

Conditions studied

  • Cancer
  • Cachexia; Cancer

Keywords

  • cancer
  • cachexia
  • nutrition
  • physical exercice
03

In context

Wasting Syndrome

196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.

This study's planned enrollment of 30 is below the median of 58 across 130 interventional studies indexed under Wasting Syndrome.

Browse Wasting Syndrome studies →

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient, male or female, over 18 years old
  • Patient operated on for a first colorectal cancer (adenocarcinoma) and requiring adjuvant chemotherapy
  • Patient with the consent of a physician to participate in the innovative muscle building program
  • Patient able to go at least once a week for 12 weeks to the Private Hospital of the Loire in Saint-Etienne (the other 2 weekly sessions that can take place in the patient's home)
  • Patient affiliated or beneficiary of a social security scheme
  • Patient having signed the free and informed consent

Exclusion criteria

Exclusion Criteria:

  • Comorbidities potentially affecting participation or test results (unstable, neuromuscular, musculoskeletal or vascular diseases affecting the lower limbs, such as radiculopathy, myopathy or neuropathy)
  • Technical necessity to convert laparoscopy into laparostomy
  • Patient unable to follow verbal instructions that could affect test and / or exercise procedures
  • Patient participating in another clinical study
  • Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, lactating or parturient woman
  • Patient hospitalized without consent.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Control chimiotherapeutic arm

    Standard care as comparaison procedure that includes chemotherapy

  • Experimental
    Physical over-activity

    The procedure under study which includes a re-training mixing EMS and EXC with a nutrition adapted to the needs related to the physical over-activity following the chemotherapy

    Dietary Supplement: Over physical activity

Interventions

  • Dietary supplementOver physical activity

    105/5000 resistance training combined with nutritional monitoring on maximum strength of knee extensors

06

What researchers measure

Primary outcomes

  1. Isometric force

    This objective will be evaluated using an isometric ergometer and the force will be expressed in Newtons. This parameter will be analyzed using a mixed linear model adjusted to the group and clinically relevant factors.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Hôpital Privé de la Loire 39
    Saint-Étienne, Loire 42100, France
    • Jean-François OUDET · Contact · 0683346567
    • Marie Barba · Contact · mh.barba@ecten.eu · +330664888704
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04136249
Lead sponsor
Ramsay Générale de Santé
Collaborators
Dr Laurent GERGELE
Responsible party
Sponsor
First posted
Oct 23, 2019
Start date
Nov 2, 2019
Primary completion
Nov 30, 2021 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Mar 10, 2020

Study contacts

Jean-François OUDET
Contact
0683346567 ext. 0683346567
Marie Barba
Contact
mh.barba@ecten.eu
+330664888704 ext. +330664888704

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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