Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03789136
Study type Observational
Source Wageningen University
Contact Klaske van Norren, PhD
Phone +31317485790
Email klaske.vannorrren@wur.nl
Status Recruiting
Phase
Start date February 24, 2017
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Withdrawn NCT03245658 - The Effect of Cannabis in Pancreatic Cancer Phase 2
Withdrawn NCT04034745 - Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
Active, not recruiting NCT03568019 - PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors
Recruiting NCT04136249 - Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study N/A
Recruiting NCT03556748 - WB-EMS and Nutrition in Patients With Hematological Malignancies N/A
Completed NCT03283488 - Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care. Phase 2
Suspended NCT04001010 - Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia Phase 3
Recruiting NCT04406662 - Routine Evaluation of People Living With Cancer
Completed NCT03524755 - Physical Exercise for Patients Who Suffer From Weight Loss Due to Head and Neck Cancer Undergoing Medical Treatment N/A
Completed NCT03316157 - Exercise and Nutritional Rehabilitation in Patients With Cancer N/A
Completed NCT03012139 - Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
Completed NCT03263520 - Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer N/A
Completed NCT04161794 - Multimodal Intervention for Patients With Non-small Cell Lung Cancer N/A
Completed NCT03743064 - A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Phase 3
Completed NCT03743051 - A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Phase 3
Recruiting NCT04353063 - Muscle Wasting in Children and Adolescents With Cancer N/A
Completed NCT04131426 - Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia Phase 1