Resection of the Esophagus and Subsequent Weight Loss

NCT03377660 | Terminated

• 1 other identifier: CRFSJ0148
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Esophageal Cancer; Weight Gain; Eating Behavior; Food Reward

Keywords

Esophagectomy; Unintentional weight loss; Gut hormones

Outcome Measures

Primary Outcomes (2)

• Change in BOLD signal

  Measure of food reward on fMRI

  Before and after 4 weeks of clinical treatment

• Change in breakpoint at PRT

  Measure of drive to eat

  Before and after 4 weeks of clinical treatment

Secondary Outcomes (2)

• Correlation of weight change during treatment with BOLD signal changes

  Before and after 4 weeks of clinical treatment

• Correlation of weight change during treatment with PRT breakpoint changes

  Before and after 4 weeks of clinical treatment

Study Arms (2)

Sandostatin

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.

Other: Clinical treatment

Mirtazapine

This cohort will be the group who are undergoing routine clinical treatment with a tetracyclic antidepressant to stimulate appetite.

Other: Clinical treatment

Interventions

Clinical treatment OTHER

Patients undergo clinical treatment as indicated, they are studied before and after.

Mirtazapine; Sandostatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A cohort of post-esophagectomy patients at least 1 year after curative surgery, but struggling with unintentional weight loss of at least 10% baseline body weight, and thus candidates for clinical treatment.

You may qualify if:

• History of esophagectomy with gastric conduit reconstruction
• Recurrence-free at least 12 months post-operatively
• Weight loss ≥10% from premorbid weight, or requiring ongoing caloric supplementation
• Due to undergo clinical treatment for weight loss with Sandostatin or Mirtazapine

You may not qualify if:

• Pregnancy, breastfeeding
• Significant and persistent chemoradiotherapy and/or surgical complication
• Other active malignancy
• Exocrine pancreatic insufficiency detected using fecal elastase
• Uncontrolled diabetes mellitus
• Significant psychiatric disorder or cognitive decline or communication impairment limiting capacity to provide informed consent
• Severe dysphagia
• Other disease or medication which may impact gut hormone physiology
• History of significant food allergy, certain dietary restrictions
• Any definite contraindication to somatostatin analogue administration
• Claustrophobia, or any absolute contraindication to MRI scanning
• Metallic implants, precluding fMRI

Sponsors & Collaborators

• Imperial College London: lead
• University College Dublin: collaborator
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

Conway Institute, UCD

Dublin, Ireland

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Weight Gain; Feeding Behavior

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of experimental pathology, Reader in investigative science

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: January 1, 2018
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)