CARE: protocol of a randomised trial evaluating the feasibility of pre-operative intentional weight loss to support post-operative recovery in patients with excess weight and colorectal cancer

Aim: excess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial.

Methods: CARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence.

Conclusion: CARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.

colorectal cancer, diet, morbidity, prehabilitation, surgery, weight loss

10.1111/codi.16687

1462-8910

1910-1920

Koutoukidis, Dimitrios A.

603f46d3-9af7-45ec-92a7-d5d3d1cd7be9

Jebb, Susan A.

c734720d-52eb-4656-a712-24398ef662f2

Foster, Claire

00786ac1-bd47-4aeb-a0e2-40e058695b73

Wheatstone, Pete

196c2edc-9149-41b3-bca2-d6ea6c976d6a

Horne, Alison

17afbbae-08d2-4356-a971-37c271136a1e

Hill, T. Martyn

d65df777-edc9-47f3-9a7d-7593e5ac5d90

Taylor, Amy

39974814-4868-4c73-a3fa-2adfa4be3e46

Realpe, Alba

76f002b0-d863-4e85-b12e-e1333821a05f

Achana, Felix

8138b374-de51-4808-8f4a-8f6871809d25

Buczacki, Simon J.A

cd630017-ae44-4da2-b321-67c644acf950

September 2023

Koutoukidis, Dimitrios A.

603f46d3-9af7-45ec-92a7-d5d3d1cd7be9

Jebb, Susan A.

c734720d-52eb-4656-a712-24398ef662f2

Foster, Claire

00786ac1-bd47-4aeb-a0e2-40e058695b73

Wheatstone, Pete

196c2edc-9149-41b3-bca2-d6ea6c976d6a

Horne, Alison

17afbbae-08d2-4356-a971-37c271136a1e

Hill, T. Martyn

d65df777-edc9-47f3-9a7d-7593e5ac5d90

Taylor, Amy

39974814-4868-4c73-a3fa-2adfa4be3e46

Realpe, Alba

76f002b0-d863-4e85-b12e-e1333821a05f

Achana, Felix

8138b374-de51-4808-8f4a-8f6871809d25

Buczacki, Simon J.A

cd630017-ae44-4da2-b321-67c644acf950

Koutoukidis, Dimitrios A., Jebb, Susan A., Foster, Claire, Wheatstone, Pete, Horne, Alison, Hill, T. Martyn, Taylor, Amy, Realpe, Alba, Achana, Felix and Buczacki, Simon J.A (2023) CARE: protocol of a randomised trial evaluating the feasibility of pre-operative intentional weight loss to support post-operative recovery in patients with excess weight and colorectal cancer. Colorectal Disease, 25 (9), 1910-1920. (doi:10.1111/codi.16687).

Record type: Article

Abstract

Text

Attached-file--CDI-00397-2023.R1 - Accepted Manuscript

Available under License Creative Commons Attribution.

Download (163kB)

Text

Colorectal Disease - 2023 - Koutoukidis - Version of Record

Available under License Creative Commons Attribution.

Download (3MB)

More information

Accepted/In Press date: 19 June 2023

Published date: September 2023

Additional Information: Funding Information: This project is sponsored by the University of Oxford and funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (grant reference no. NIHR204051). DAK is also supported by an NIHR Advanced Fellowship (NIHR302549). SAJ is also funded by the Oxford NIHR Applied Research Collaboration. SJAB is supported by The Pharsalia Trust, UK and Cancer Research UK Advanced Clinician Scientist Fellowship (C14094/A27178). The funder has no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The sponsor has no role in the collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The ultimate authority over any of these activities lies with the study investigators. The views expressed are those of the author (s) and not necessarily those of the NIHR or the Department of Health and Social Care. Publisher Copyright: © 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.

Keywords: colorectal cancer, diet, morbidity, prehabilitation, surgery, weight loss

Learn more about Institute for Life Sciences research