Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery

Abstract Background While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol pa...

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Autores principales:	T. X. Wong, S. T. Chen, S. H. Ong, S. Shyam, P. Kandasami, W. S. S. Chee
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Perioperative oral nutrition supplement Breast cancer Colorectal cancer Non-severe malnutrition Surgical outcomes Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/10e4ef239f534c0fbec11c596b79c87d
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spelling	oai:doaj.org-article:10e4ef239f534c0fbec11c596b79c87d2021-11-08T11:02:55ZStudy protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery10.1186/s13063-021-05716-51745-6215https://doaj.org/article/10e4ef239f534c0fbec11c596b79c87d2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05716-5https://doaj.org/toc/1745-6215Abstract Background While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer. Methods Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate. Discussion This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes. Trial registration ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registeredT. X. WongS. T. ChenS. H. OngS. ShyamP. KandasamiW. S. S. CheeBMCarticlePerioperative oral nutrition supplementBreast cancerColorectal cancerNon-severe malnutritionSurgical outcomesMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-17 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Perioperative oral nutrition supplement Breast cancer Colorectal cancer Non-severe malnutrition Surgical outcomes Medicine (General) R5-920
spellingShingle	Perioperative oral nutrition supplement Breast cancer Colorectal cancer Non-severe malnutrition Surgical outcomes Medicine (General) R5-920 T. X. Wong S. T. Chen S. H. Ong S. Shyam P. Kandasami W. S. S. Chee Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
description	Abstract Background While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer. Methods Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate. Discussion This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes. Trial registration ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered
format	article
author	T. X. Wong S. T. Chen S. H. Ong S. Shyam P. Kandasami W. S. S. Chee
author_facet	T. X. Wong S. T. Chen S. H. Ong S. Shyam P. Kandasami W. S. S. Chee
author_sort	T. X. Wong
title	Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
title_short	Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
title_full	Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
title_fullStr	Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
title_full_unstemmed	Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
title_sort	study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery
publisher	BMC
publishDate	2021
url	https://doaj.org/article/10e4ef239f534c0fbec11c596b79c87d
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Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery

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