Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

NCT02573974 | Completed

• 4 other identifiers: PHAO14-TL/METERMUCADIG2015-A00683-462015-R25150963B-12
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Undernutrition; Gastrointestinal Cancer

Keywords

undernutrition; gastrointestinal cancer; skeletal muscle; energy metabolism

Outcome Measures

Primary Outcomes (1)

• Measurement of muscle mitochondrial bioenergetics

  Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

  An average of one week

Secondary Outcomes (4)

• Quantification of muscle lipid droplets

  An average of one week

• Analysis of the expression of target genes and proteins

  An average of one week

• Determination of body composition (fat mass / lean mass)

  Within 4 weeks before inclusion

• Determining the isotopic composition of nitrogen hair

  An average of one week

Study Arms (2)

Case group

OTHER

the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer

Other: Samples

Control group

OTHER

the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer

Other: Samples

Interventions

Samples OTHER

Blood samples, muscle biopsy and sample of hair

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding women
• Unbalanced Diabetes
• Systemic corticosteroid treatment
• Any severe uncontrolled medical condition
• Alopecia
• Control group selection criteria:
• years ≤ Age ≤ 80 years
• Colorectal pancreatic cancer
• Indication adjuvant 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
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Tours: lead
• Inserm U1069 - Team Nutrition, Growth and Cancer: collaborator

Study Sites (1)

Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS

Tours, 37044, France

Location

Related Publications (1)

• Dolly A, Lecomte T, Tabchouri N, Caulet M, Michot N, Anon B, Chautard R, Desvignes Y, Ouaissi M, Fromont-Hankard G, Dumas JF, Servais S. Pectoralis major muscle atrophy is associated with mitochondrial energy wasting in cachectic patients with gastrointestinal cancer. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1837-1849. doi: 10.1002/jcsm.12984. Epub 2022 Mar 22.

  PMID: 35316572 RESULT

MeSH Terms

Conditions

Malnutrition; Gastrointestinal Neoplasms

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Thierry LECOMTE, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 12, 2015
• Study Start: January 19, 2016
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)