Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Body Weight

Weight Loss

Body Weight Changes

Thinness

Hematinics

All Drugs and Chemicals

Herbal and Botanical

Liver Extracts

Cola

Not applicable, observational study

Klaske van Norren, PhD

Dik Snijdelaar, md

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.

For the control group the investigators include men with inguinal hernia and women eligible for abdominal hysterectomy.

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

Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis

Measured using single slice staining of CT scan made for diagnostic purposes.

Measured in a muscle biopsy taken from the rectus abdominis

Adipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat

Blood plasma cytokine levels measured using multiplex or similar technique

Micro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques

Cholesterol levels in the blood measured by GCMS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism	NCT03789136	Cachexia; Cance...	Not applicable,...	-	Wageningen University
The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism	NCT03789136	Cachexia; Cance...	Not applicable,...	-	Wageningen University

Spots Global Cancer Trial Database for not applicable, observational study