Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia

NCT05954117 | Not Yet Recruiting

• 2 other identifiers: AOI 2022 RICHARD2023-A00582-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Adenocarcinoma

Keywords

Mitochondria; Oxygraphy; Adipose Tissue; Gastroesophageal adenocarcinoma; Energy expenditure

Outcome Measures

Primary Outcomes (1)

• 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.

  6 week

Secondary Outcomes (2)

• Evaluation of sarcopenia (SARC-F : sarcopenia scoring)

  1 week

• anthropometric data

  1 week

Study Arms (1)

Interventional

EXPERIMENTAL

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

Procedure: Adipose tissue biopsies

Interventions

Adipose tissue biopsies PROCEDURE

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.

Interventional

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Université d'Auvergne: collaborator
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Related Publications (1)

• Bacoeur-Ouzillou O, Guerrier L, Touron J, Pinel A, Pereira B, Meunier N, Gillet B, Pezet D, Cassagnes L, Malpuech-Brugere C, Richard R, Gagniere J. Chemotherapy effects on mitochondrial function in adipose tissue in oesophageal and gastroesophageal junction adenocarcinomas with or without associated cachexia: protocol for a prospective, comparative observational study (ChiFMeOE). BMJ Open. 2024 Oct 23;14(10):e086686. doi: 10.1136/bmjopen-2024-086686.

  PMID: 39448207 DERIVED

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Study Officials

• Ruddy RICHARD

  Ruddy.Richard@Uca.Fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patient undergoing surgery for esophageal adenocarcinoma or for gastroesophageal adenocarcinoma

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 20, 2023
• Study Start: July 25, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 20, 2023

Record last verified: 2023-06

Locations

FR (1)