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

NCT03789136 | Unknown

• 1 other identifier: NL58188.081.16
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cachexia; Cancer

Outcome Measures

Primary Outcomes (1)

• Muscle gene expression

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

  Biopsy during surgery

Secondary Outcomes (7)

• Body composition

  Before surgery

• Muscle function

  Before surgery

• Muscle protein metabolism

  Biopsy during surgery

• Adipose tissue gene expression

  Biopsy during surgery

• Cytokine parameters in the blood

  Blood taken prior to surgery

Study Arms (4)

Primary colon cancer

Other: Not applicable, observational study

Liver metastases

Other: Not applicable, observational study

Inguinal hernia (control)

Other: Not applicable, observational study

Abdominal hysterectomy (control)

Other: Not applicable, observational study

Interventions

Not applicable, observational study OTHER

Not applicable, observational study

Abdominal hysterectomy (control); Inguinal hernia (control); Liver metastases; Primary colon cancer

Eligibility Criteria

• Gender Eligibility Details: For the control group the investigators include men with inguinal hernia and women eligible for abdominal hysterectomy.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 colon cancer (CC) patients (♀ and ♂) undergoing primary tumor resection operation (30 patients) or liver metastases surgery (10 patients) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5) will be included in the study. Since the investigators do not know the number of patients in the colon cancer group willing to cooperate in the study, the investigators decided to take 5 patients of each control group (50% men and women). Note: during the study the investigators see more men than women joining the study so therefore the investigators raised the number of male controls to 10.

You may qualify if:

• CC patients:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Gelderse Vallei Hospital: collaborator
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Gelderse Vallei Hospital

Ede, Gelderland, 6716 RP, Netherlands

RECRUITING

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Klaske van Norren, PhD

  Wageningen University and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaske van Norren, PhD

CONTACT

+31317485790; klaske.vannorrren@wur.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 28, 2018
• Study Start: February 24, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)