Clinical trial · Interventional
Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study
NCT04136249CI-TRIAL-00043932ColCanterunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia; Cancer | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Over physical activity | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control chimiotherapeutic arm
- description
- Standard care as comparaison procedure that includes chemotherapy
- type
- EXPERIMENTAL
- label
- Physical over-activity
- 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
- interventionNames
- Dietary Supplement: Over physical activity
Primary outcomes (1)
- measure
- Isometric force
- timeFrame
- 3 months
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.