Resection of the Esophagus and Subsequent Weight Loss

NCT ID: NCT03377660

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-06-01

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.

Detailed Description

The incidence of cancer of the oesophagus (food pipe) is increasing. Improvements in treatment strategies have resulted in more people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with oesophageal cancer, but while surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Poor appetite, weight loss and nutritional impairment are common problems among patients who attain long-term cancer remission and cure after surgery.

A new clinic has been established to treat patients who are in remission but who have lost more than 10% of their body weight secondary to the effects of the surgery and struggling to regain weight. These patients will be treated as per standard of care with medications to aid weight gain.

The investigators are interested to conduct research into how the reward value of food changes during the clinical treatment pathway. The hypothesis is that there will be an increased reward response to food after medication use, the magnitude of which will correlate with weight gain. To assess this, patients who are already part of this clinic will be approached to have fMRI that can demonstrate changes in brain reward centres as well as a Progressive Ratio Task, which is a direct measure of appetitive behaviour. Changes in brain reward centre responses and appetitive behaviour will be correlated with changes in weight after pharmacotherapy. This may further inform future clinical protocols to provide improved precision medicine.

Conditions

Esophageal Cancer; Weight Gain; Eating Behavior; Food Reward

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Clinical treatment

Intervention Type: OTHER

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

Mirtazapine

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

Clinical treatment

Intervention Type: OTHER

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

Interventions

Clinical treatment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Dublin

OTHER

Sponsor Role: collaborator

St. James's Hospital, Ireland

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Carel Le Roux

Professor of experimental pathology, Reader in investigative science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Conway Institute, UCD

Dublin, , Ireland

Countries

Ireland

Other Identifiers

CRFSJ0148

Identifier Type: -

Identifier Source: org_study_id