Clinical trial · Observational
Resection of the Esophagus and Subsequent Weight Loss
The Effect of Clinical Treatment for Unintentional Weight Loss on Food Reward and Appetitive Behaviour in Patients Who Have Lost >10% of Their Body Weight After Undergoing Curative Surgery for Oesophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding stopped.
Summary
Brief summary (as posted)
The investigators aim to ascertain how food reward signals and eating behaviour relates to the gut-brain pathway in weight-losing patients after curative surgery for oesophageal cancer, and how this pathway responds to clinical treatment for this unintentional weight loss. The primary outcomes are the blood oxygen level dependent (BOLD) signal on functional MRI (fMRI), and the breakpoint during the progressive ratio task (PRT - a measure of eating behaviour), how these differ in response to multiple clinical treatment options, as well as how they relate to weight gain while on treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Eating Behavior | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Food Reward | — | UNRESOLVED | — |
| Weight Gain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Sandostatin
- description
- This cohort will be the group who are undergoing routine clinical treatment with a long-acting somatostatin analogue to minimise abnormal gut hormone signalling, and thus reduce early satiety.
- interventionNames
- Other: Clinical treatment
- label
- Mirtazapine
- description
- This cohort will be the group who are undergoing routine clinical treatment with a tetracyclic antidepressant to stimulate appetite.
- interventionNames
- Other: Clinical treatment
Primary outcomes (2)
- measure
- Change in BOLD signal
- timeFrame
- Before and after 4 weeks of clinical treatment
- description
- Measure of food reward on fMRI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. History of esophagectomy with gastric conduit reconstruction 2. Recurrence-free at least 12 months post-operatively 3. Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation 4. Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine Exclusion Criteria: 1. Pregnancy, breastfeeding 2. Significant and persistent chemoradiotherapy and/or surgical complication 3. Other active malignancy 4. Exocrine pancreatic insufficiency detected using fecal elastase 5. Uncontrolled diabetes mellitus 6. Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent 7. Severe dysphagia 8. Other disease or medication which may impact gut hormone physiology 9. History of significant food allergy, certain dietary restrictions 10. Any definite contraindication to somatostatin analogue administration 11. Claustrophobia, or any absolute contraindication to MRI scanning 12. Metallic implants, precluding fMRI
References
Publications (0)
Data not yet available