Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer (METERMUCADIG)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Gastrointestinal Cancer; Undernutrition

Treatments: Other: Samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02573974

2015-R25 (Other Identifier)

150963B-12 (Other Identifier)

PHAO14-TL/METERMUCADIG

2015-A00683-46 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Case group selection 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
• Alopecia

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
• 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
• Undernutrition related cancer (weight loss > 5% weight in one month or 10% in 6 months)
• Unbalanced Diabetes
• Systemic corticosteroid treatment
• Any severe uncontrolled medical condition
• Alopecia

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Case group

Other group

Description:

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

Treatment:

Other: Samples

Control group

Other group

Description:

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

Treatment:

Other: Samples