Unintentional Weight Loss After Oesophagectomy

NCT05074914 | Unknown DMC

• 1 other identifier: UWL-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of cancer of the oesophagus is increasing. While surgical removal of the tumour (oesophagectomy) may offer the best chance of cure, such major operations are associated with long-term complications such as poor appetite, unintentional weight loss and nutritional impairments. In the long-term, unintentional weight loss of 10-30% increases the risk of disease and death. However, a knowledge gap exists as there has been no comprehensive assessment of how this surgery changes the mechanisms of how the gut communicates with the brain (gut-brain pathways) and its relation to food intake and eating behaviour. The aims of this study are to test the hypotheses that:

1. 1.Oesophagectomy induces changes in the small intestine barrier (gut mucosa) and changes in hormonal signals after food consumption.
2. 2.Oesophagectomy reduces appetite, eating behaviour, and food intake and shifts food selection from high-fat and high-glycaemic index items (quickly digested carbohydrates) to low-fat and low-glycaemic index items (slowly digested).

Conditions

Oesophageal Cancer

Outcome Measures

Primary Outcomes (8)

• Measurement of the change in appetitive behaviour from baseline (before oesophagectomy) until 2 years following oesophagectomy using a progressive ratio task.

  measured using Progressive ratio task

  0, 6, 12 and 24 months

• Direct measurement of changes in food intake from baseline (before oesophagectomy) until two years postoperatively using a standard buffet meal and weighing the specific foods before and after consumption.

  weighted measurement of food consumed before and after eating

  0, 6, 12 and 24 months

• Direct measurement of changes in food selection from baseline (before oesophagectomy) until two years postoperatively using a standard buffet meal and observing the specific foods selection before and after consumption.

  observed measurement of food selection before and after eating

  0, 6, 12 and 24 months

• Measurement of the change in postprandial gut hormone profiles from baseline (before oesophagectomy) until two years following oesophagectomy.

  Measured through plasma hormone levels taken before and after food consumption

  Every 30 minutes over a two hour period at 0, 6, 12 and 24 months

• Measurement of the change in plasma bile acid profiles from baseline (before oesophagectomy) until two years following oesophagectomy.

  Measured through plasma bile levels taken before and after food consumption

  Every 30 minutes over a two hour period at 0, 6, 12 and 24 months

• Measurement of the change in faecal gut microbiota from baseline (before oesophagectomy) until two years following oesophagectomy.

  Measured through stool samples and observation of changes to bacteria present

  Every 30 minutes over a two hour period at 0, 6, 12 and 24 months

• Quantification of changes in enteroendocrine cells in the mucosa of the proximal small bowel at baseline (before oesophagectomy) until 2 years postoperatively.

  Measured through biopsy

  Baseline and up to 24 months postoperatively

• Quantification of changes in gut microbiota in the mucosa of the proximal small bowel at baseline before oesophagectomy until 2 years postoperatively.

  Measured through biopsy

  Baseline and up to 24 months postoperatively

Study Arms (2)

Adenocarcinoma of the oesophagus

EXPERIMENTAL

curative oesophagectomy

Procedure: oesophagectomy

Barrett's oesophagus

NO INTERVENTION

Weight stable patient under survelliance with Barrett's oespophagus

Interventions

oesophagectomy PROCEDURE

removal of oesophagus

Adenocarcinoma of the oesophagus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Oesophageal adenocarcinoma group:
• Planned for oesophagectomy with gastric conduit reconstruction
• Recurrence-free at least 12 months post-operatively
• Weight loss ≥10% from premorbid weight or require ongoing caloric supplementation
• B. Barrett's oesophagus group:
• Barrett's oesophagus group who are under surveillance from INCEUGIN

You may not qualify if:

• Pregnant or breastfeeding, or planning to become pregnant
• Unable to swallow or need frequent dilatations ("stretches")
• Unable to eat semisolid food
• Allergies or dietary intolerance
• Diabetes mellitus type 1
• Reoccurrence of disease after surgery or are having another active form of cancer
• Taking medication which may impact gut hormone physiology
• Unstable cardiovascular disease
• A significant neurological condition
• A previous upper gastrointestinal resection
• A medical condition that would limit the ability to take part, that might impact certain test results or might make it unsafe for the patient to take these treatments.
• Difficulty reading, understanding or remembering the information we have given.
• Previous abdominal surgery.
• Treatment with GLP-1 receptor agonists or DPP-IV inhibitor or insulin

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

St James University Hospital Clinical Research Centre

Dublin, Dublin 8, Ireland

RECRUITING

Related Publications (5)

• Stahl M, Mariette C, Haustermans K, Cervantes A, Arnold D; ESMO Guidelines Working Group. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi51-6. doi: 10.1093/annonc/mdt342. No abstract available.

  PMID: 24078662 BACKGROUND

• Wilke TJ, Bhirud AR, Lin C. A review of the impact of preoperative chemoradiotherapy on outcome and postoperative complications in esophageal cancer patients. Am J Clin Oncol. 2015 Aug;38(4):415-21. doi: 10.1097/COC.0000000000000021.

  PMID: 24351783 BACKGROUND

• Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.

  PMID: 26254683 BACKGROUND

• Baker M, Halliday V, Williams RN, Bowrey DJ. A systematic review of the nutritional consequences of esophagectomy. Clin Nutr. 2016 Oct;35(5):987-94. doi: 10.1016/j.clnu.2015.08.010. Epub 2015 Sep 12.

  PMID: 26411750 BACKGROUND

• Martin L, Lagergren P. Long-term weight change after oesophageal cancer surgery. Br J Surg. 2009 Nov;96(11):1308-14. doi: 10.1002/bjs.6723.

  PMID: 19847871 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Carel Le Roux, Pr, MD

  University College Dublin

  STUDY CHAIR

Central Study Contacts

Carel Le Roux, Pr, MD

CONTACT

+353864117842; carel.leroux@ucd.ie

Roshaida Abdul Wahab, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: October 12, 2021
• Study Start: June 30, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)