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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03789136
Acronym
COMUNEX
Enrollment
55
Registered
2018-12-28
Start date
2017-02-24
Completion date
2022-12-31
Last updated
2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia; Cancer

Brief summary

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.

Interventions

Not applicable, observational study

Sponsors

Gelderse Vallei Hospital
CollaboratorOTHER
Top Institute Food and Nutrition
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* CC patients: In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria: * Diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10) * Eligible for a primary tumor or liver metastases resection procedure * Controls: * Eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5)

Exclusion criteria

* CC patients: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Having had chemotherapy or an operational procedure of the abdomen in the past 6 months * Suffering from malabsorption * Controls: * Having had treatment for previous or current tumors

Design outcomes

Primary

MeasureTime frameDescription
Muscle gene expressionBiopsy during surgeryMuscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis

Secondary

MeasureTime frameDescription
Muscle functionBefore surgeryMeasured using hand-grip strength
Muscle protein metabolismBiopsy during surgeryMeasured in a muscle biopsy taken from the rectus abdominis
Adipose tissue gene expressionBiopsy during surgeryAdipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat
Body compositionBefore surgeryMeasured using single slice staining of CT scan made for diagnostic purposes.
Micro-nutrient parameters in the bloodBlood taken prior to surgeryMicro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques
Cholesterol levels in the bloodBlood taken prior to surgeryCholesterol levels in the blood measured by GCMS
Cytokine parameters in the bloodBlood taken prior to surgeryBlood plasma cytokine levels measured using multiplex or similar technique

Countries

Netherlands

Contacts

Primary ContactKlaske van Norren, PhD
klaske.vannorrren@wur.nl+31317485790

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026