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NCT03789136: COMUNEX

The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism

Status unknown Last updated 29 June 2021
What this trial tests

trial testing Not applicable, observational study in Cachexia; Cancer in 55 participants. Status unknown.

Timeline
24 February 2017
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorWageningen University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment55
Start date24 February 2017
Primary completion31 December 2022
Estimated completion31 December 2022
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Wageningen University

Who can join

Eligibility, any sex, with Cachexia; Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance. Objective: Main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls. Study design: Observational study Study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5). Main study parameters/endpoints: Primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary parameters will be body composition (determined in available CT scans and bio impedance analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators expect no additional risk for the subjects due to the proposed measurements. Biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. All other measurements are non-invasive, observational measurements with no risk of any harmful side effects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Primary-Stage Colon Cancer Impairs Muscle Energy Metabolism by Suppressing Mitochondrial Complex I Activity.
    Li X, van der Ende M, Moonen H, Plas R, et al · · 2025 · cited 1× · PMID 41221702 · DOI 10.1002/jcsm.70117

Verify or expand the search:

Other recruiting trials for Cachexia; Cancer

Currently open trials in the same condition.

Other Wageningen University trials

Trials by the same sponsor.

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Data sources for this page

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