Skip to main content
Clinical Trials/NCT02573974
NCT02573974
Completed
Not Applicable

Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

University Hospital, Tours1 site in 1 country51 target enrollmentJanuary 19, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Undernutrition
Sponsor
University Hospital, Tours
Enrollment
51
Locations
1
Primary Endpoint
Measurement of muscle mitochondrial bioenergetics
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.

Registry
clinicaltrials.gov
Start Date
January 19, 2016
End Date
December 4, 2018
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years ≤ Age ≤ 80 years
  • Colorectal pancreatic cancer
  • Undernutrition related to cancer (weight loss \> 5% weight in one month or 10% in 6 months)
  • Indication to systemic chemotherapy
  • Indication to the development of an implantable port
  • Life expectancy ≥ 3 months
  • WHO General Status ≤ 2
  • Patients affiliated to social security scheme
  • Informed consent signed by the patient

Exclusion Criteria

  • Pregnant or breastfeeding women
  • Unbalanced Diabetes
  • Systemic corticosteroid treatment
  • Any severe uncontrolled medical condition
  • Control group selection criteria:
  • Inclusion Criteria:
  • 18 years ≤ Age ≤ 80 years
  • Colorectal pancreatic cancer
  • Indication adjuvant chemotherapy
  • Indication to the development of an implantable port

Outcomes

Primary Outcomes

Measurement of muscle mitochondrial bioenergetics

Time Frame: An average of one week

Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary Outcomes

  • Quantification of muscle lipid droplets(An average of one week)
  • Analysis of the expression of target genes and proteins(An average of one week)
  • Determining the isotopic composition of nitrogen hair(An average of one week)
  • Determination of body composition (fat mass / lean mass)(Within 4 weeks before inclusion)

Study Sites (1)

Loading locations...

Similar Trials