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

Cachexia; Cancer Clinical Trial

— COMUNEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789136
• Other study ID #: NL58188.081.16
• Status: Recruiting
• Start date: February 24, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Wageningen University
• Contact: Klaske van Norren, PhD
• Phone: +31317485790
• Email: klaske.vannorrren[@]wur.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cachexia; Cancer

Intervention

Other:
• Not applicable, observational study
Not applicable, observational study

Locations

Country	Name	City	State
Netherlands	Gelderse Vallei Hospital	Ede	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Gelderse Vallei Hospital, Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle gene expression	Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis	Biopsy during surgery
Secondary	Body composition	Measured using single slice staining of CT scan made for diagnostic purposes.	Before surgery
Secondary	Muscle function	Measured using hand-grip strength	Before surgery
Secondary	Muscle protein metabolism	Measured in a muscle biopsy taken from the rectus abdominis	Biopsy during surgery
Secondary	Adipose tissue gene expression	Adipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat	Biopsy during surgery
Secondary	Cytokine parameters in the blood	Blood plasma cytokine levels measured using multiplex or similar technique	Blood taken prior to surgery
Secondary	Micro-nutrient parameters in the blood	Micro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques	Blood taken prior to surgery
Secondary	Cholesterol levels in the blood	Cholesterol levels in the blood measured by GCMS	Blood taken prior to surgery