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

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ClinicalTrials.gov Identifier: NCT03789136
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborators:
Gelderse Vallei Hospital
Top Institute Food and Nutrition
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Cachexia; Cancer Other: Not applicable, observational study

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Primary colon cancer Other: Not applicable, observational study
Not applicable, observational study

Liver metastases Other: Not applicable, observational study
Not applicable, observational study

Inguinal hernia (control) Other: Not applicable, observational study
Not applicable, observational study

Abdominal hysterectomy (control) Other: Not applicable, observational study
Not applicable, observational study




Primary Outcome Measures :
  1. Muscle gene expression [ Time Frame: Biopsy during surgery ]
    Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis


Secondary Outcome Measures :
  1. Body composition [ Time Frame: Before surgery ]
    Measured using single slice staining of CT scan made for diagnostic purposes.

  2. Muscle function [ Time Frame: Before surgery ]
    Measured using hand-grip strength

  3. Muscle protein metabolism [ Time Frame: Biopsy during surgery ]
    Measured in a muscle biopsy taken from the rectus abdominis

  4. Adipose tissue gene expression [ Time Frame: Biopsy during surgery ]
    Adipose tissue gene expression measured using PCR or micro-array in abdominal and subcutaneous fat

  5. Cytokine parameters in the blood [ Time Frame: Blood taken prior to surgery ]
    Blood plasma cytokine levels measured using multiplex or similar technique

  6. Micro-nutrient parameters in the blood [ Time Frame: Blood taken prior to surgery ]
    Micro-nutrient levels in the blood measured using LCMS, ELISA or similar techniques

  7. Cholesterol levels in the blood [ Time Frame: Blood taken prior to surgery ]
    Cholesterol levels in the blood measured by GCMS



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   For the control group the investigators include men with inguinal hernia and women eligible for abdominal hysterectomy.
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789136


Contacts
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Contact: Klaske van Norren, PhD +31317485790 klaske.vannorrren@wur.nl

Locations
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Netherlands
Gelderse Vallei Hospital Recruiting
Ede, Gelderland, Netherlands, 6716 RP
Contact: Dik Snijdelaar, md       snijdelaarD@zgv.nl   
Sponsors and Collaborators
Wageningen University
Gelderse Vallei Hospital
Top Institute Food and Nutrition
Investigators
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Principal Investigator: Klaske van Norren, PhD Wageningen University and Research

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT03789136     History of Changes
Other Study ID Numbers: NL58188.081.16
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms