Clinical trial · Interventional
Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia
Effect of Chemotherapy on Metabolic Flexibility in the Context of Cachexia in Cancers of the Esophagus and Gastroesophageal Junction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adipose tissue biopsies | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- patients with esophageal or gastroesophageal adenocarcinoma included to evaluate the energy expenditure before and after chemotherapy and evaluate parameters of cachexia
- interventionNames
- Procedure: Adipose tissue biopsies
Primary outcomes (1)
- measure
- Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
- timeFrame
- 6 week
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBacoeur-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