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Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia (CHIFMEOE)

Primary Purpose

Esophageal Adenocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adipose tissue biopsies
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Esophageal Adenocarcinoma focused on measuring Mitochondria, Oxygraphy, Adipose Tissue, Gastroesophageal adenocarcinoma, Energy expenditure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Male Patients Patients aged over 18 Patients eligible for neoadjuvant FLOT chemotherapy (5-fluorouracil, oxaliplatin, docetaxel); Patients with a resealable adenocarcinoma of esophageal or gastroesophageal Patients able to give informed consent. Patients affiliated to a Health Care insurance Exclusion Criteria: Unresectable or metastatic esophageal or gastroesophageal adenocarcinoma; Another tumor histology than adenocarcinoma. Patients not eligible for neoadjuvant FLOT chemotherapy and/or for surgery Patients under guardianship, curators or deprived of liberty; Refusal to participate; Patients already participating in another interventional study of pharmacological, nutritional and/or rehabilitation study; Patients in a period of exclusion from another research protocol.

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

patients with esophageal or gastroesophageal adenocarcinoma included to evaluate the energy expenditure before and after chemotherapy and evaluate parameters of cachexia

Outcomes

Primary Outcome Measures

Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
Evaluation of mitochondrial respiration on adipose tissue before and after chemotherapy Mitochondrial respiration measurements in oxydo-phosphorylated conditions. For each patient measurements using ADP and carbohydrate or lipid substrates of the respiratory chain complexes for both the subcutaneous and the visceral tissue.

Secondary Outcome Measures

Evaluation of sarcopenia (SARC-F : sarcopenia scoring)
level of sarcopenia between 0 to 12 including 5 questions
anthropometric data
BMI will be measured

Full Information

First Posted
June 16, 2023
Last Updated
July 19, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne, CRNH Auvergne, Ligue contre le cancer, France
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1. Study Identification

Unique Protocol Identification Number
NCT05954117
Brief Title
Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia
Acronym
CHIFMEOE
Official Title
Effect of Chemotherapy on Metabolic Flexibility in the Context of Cachexia in Cancers of the Esophagus and Gastroesophageal Junction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 25, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Université d'Auvergne, CRNH Auvergne, Ligue contre le cancer, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cachexia is a syndrome frequently associated with digestive cancers and more particularly with esophageal and gastroesophageal adenocarcinoma. Its pathophysiology remains poorly understood, multi-factorial, but strongly correlated to the prognosis of patients. It's a consequence of the imbalance of energy balance linked to tumoral process, to dysphagia and to anorexia, frequently present in these cancers. At the center of this imbalance, adipose tissue plays a major role. Recent studies showing that the mobilization of lipid substrates and the hypermetabolism of adipocytes are involving in its development, even before loss of muscle. As part of the management, neoadjuvant chemotherapy is usually administered with the main objective to reduce tumor extension and dissemination through actions on DNA and mitosis. These treatments will also alter the mitochondrial function of cells in other tissues, probably including that of adipocytes. A paradoxical effect on the cachectic process could thus be envisaged, as a decrease in mitochondrial activity and associated hypermetabolism, and therefore a preservation of fat mass, and by extension of muscle mass. Primary endpoint: identify the adipocyte factors involved in the energy imbalance associated with the cachectic process in patients managed for esophageal or gastroesophageal adenocarcinoma. Secondary endpoint: compare the results obtained before and after chemotherapy treatment according to the cachectic state and the anatomical location of the adipose sample (subcutaneous versus visceral) to evaluate the resting energy expenditure.
Detailed Description
Two operative steps, separated by neoadjuvant chemotherapy, are classically planned in the management of esophageal and gastroesophageal adenocarcinoma: an exploratory laparoscopy as part of the disease extension assessment and the tumor resection surgery (esophagectomy). During these operations, the surgeon will perform a subcutaneous fat biopsy at the surgical approach and a visceral fat biopsy at the epiploic level. A portion of the samples will be immediately analyzed by high-resolution oxygraphy to evaluate the mitochondrial metabolism of the adipocytes. The rest of biopsies will be frozen for further biological analysis (enzymology, Western-blot, RT-qPCR) or embedded in paraffin for histological analysis (morphometry, inflammation, metabolism). Serum will also be recovered with the biopsies for specific biological analysis (inflammatory and lipid status). In days preceding the interventions, in addition to the usual management, will be performed: an evaluation of the energy expenditure by indirect calorimetry, an evaluation of the body composition by Dual Energy X-ray Absorptiometry (DEXA), physical tests to evaluate sarcopenia and cachexia, nutritional and quality of life questionnaires, and a medical examination with a dietetic consultation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Adenocarcinoma
Keywords
Mitochondria, Oxygraphy, Adipose Tissue, Gastroesophageal adenocarcinoma, Energy expenditure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patient undergoing surgery for esophageal adenocarcinoma or for gastroesophageal adenocarcinoma
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
patients with esophageal or gastroesophageal adenocarcinoma included to evaluate the energy expenditure before and after chemotherapy and evaluate parameters of cachexia
Intervention Type
Procedure
Intervention Name(s)
Adipose tissue biopsies
Intervention Description
During the 2 surgical time, when patient is under general anesthesia, two adipose tissue biopsies of 20cc each (one from abdominal subcutaneous adipose tissue and one from omental adipose tissue) are taken and characterize by oxygraphy (respirometry). Before the 2 surgical times (before and after chemotherapy) patients will have evaluation of the muscle strength, cachexia (by scan analysis), energy expenditure, anthropometric criteria and biochemical inflammatory.
Primary Outcome Measure Information:
Title
Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
Description
Evaluation of mitochondrial respiration on adipose tissue before and after chemotherapy Mitochondrial respiration measurements in oxydo-phosphorylated conditions. For each patient measurements using ADP and carbohydrate or lipid substrates of the respiratory chain complexes for both the subcutaneous and the visceral tissue.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Evaluation of sarcopenia (SARC-F : sarcopenia scoring)
Description
level of sarcopenia between 0 to 12 including 5 questions
Time Frame
1 week
Title
anthropometric data
Description
BMI will be measured
Time Frame
1 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male Patients Patients aged over 18 Patients eligible for neoadjuvant FLOT chemotherapy (5-fluorouracil, oxaliplatin, docetaxel); Patients with a resealable adenocarcinoma of esophageal or gastroesophageal Patients able to give informed consent. Patients affiliated to a Health Care insurance Exclusion Criteria: Unresectable or metastatic esophageal or gastroesophageal adenocarcinoma; Another tumor histology than adenocarcinoma. Patients not eligible for neoadjuvant FLOT chemotherapy and/or for surgery Patients under guardianship, curators or deprived of liberty; Refusal to participate; Patients already participating in another interventional study of pharmacological, nutritional and/or rehabilitation study; Patients in a period of exclusion from another research protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruddy RICHARD
Organizational Affiliation
Ruddy.Richard@Uca.Fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia

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