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Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

NCT ID: NCT02573974

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-19

Study Completion Date

2018-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Undernutrition Gastrointestinal Cancer

Keywords

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undernutrition gastrointestinal cancer skeletal muscle energy metabolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Case group

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

Group Type OTHER

Samples

Intervention Type OTHER

Blood samples, muscle biopsy and sample of hair

Control group

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

Group Type OTHER

Samples

Intervention Type OTHER

Blood samples, muscle biopsy and sample of hair

Interventions

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Samples

Blood samples, muscle biopsy and sample of hair

Intervention Type OTHER

Eligibility Criteria

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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


* 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
* Unbalanced Diabetes
* Systemic corticosteroid treatment
* Any severe uncontrolled medical condition
* Alopecia

Control group selection 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inserm U1069 - Team Nutrition, Growth and Cancer

UNKNOWN

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry LECOMTE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35316572 (View on PubMed)

Other Identifiers

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2015-A00683-46

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-R25

Identifier Type: OTHER

Identifier Source: secondary_id

150963B-12

Identifier Type: OTHER

Identifier Source: secondary_id

PHAO14-TL/METERMUCADIG

Identifier Type: -

Identifier Source: org_study_id