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

• Conditions: Cachexia; Cancer
• Interventions: Other: Not applicable, observational study

• Registration Number: NCT03789136
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-24
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inguinal hernia (control)	Not applicable, observational study	-
Primary colon cancer	Not applicable, observational study	-
Liver metastases	Not applicable, observational study	-
Abdominal hysterectomy (control)	Not applicable, observational study	-

Primary Outcome Measures

Name	Time	Method
Muscle gene expression	Biopsy during surgery	Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gelderse Vallei Hospital; 🇳🇱 Ede, Gelderland, Netherlands