Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study (ColCanter)
Primary Purpose
Cancer, Cachexia; Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Over physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring cancer, cachexia, nutrition, physical exercice
Eligibility Criteria
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:
- 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.
Sites / Locations
- Hôpital Privé de la Loire 39Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control chimiotherapeutic arm
Physical over-activity
Arm Description
Standard care as comparaison procedure that includes chemotherapy
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04136249
First Posted
October 21, 2019
Last Updated
March 9, 2020
Sponsor
Ramsay Générale de Santé
Collaborators
Dr Laurent GERGELE
1. Study Identification
Unique Protocol Identification Number
NCT04136249
Brief Title
Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study
Acronym
ColCanter
Official Title
Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Dr Laurent GERGELE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cachexia; Cancer
Keywords
cancer, cachexia, nutrition, physical exercice
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control chimiotherapeutic arm
Arm Type
No Intervention
Arm Description
Standard care as comparaison procedure that includes chemotherapy
Arm Title
Physical over-activity
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Over physical activity
Intervention Description
105/5000 resistance training combined with nutritional monitoring on maximum strength of knee extensors
Primary Outcome Measure Information:
Title
Isometric force
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François OUDET
Phone
0683346567
Ext
0683346567
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Hôpital Privé de la Loire 39
City
Saint-Étienne
State/Province
Loire
ZIP/Postal Code
42100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François OUDET
Phone
0683346567
Ext
0683346567
First Name & Middle Initial & Last Name & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study
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