Abstract
BackgroundWhile 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.MethodsPatients 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.DiscussionThis 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 registrationClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered
Highlights
Background and rationale {6a} The incidence of cancer is on an increasing trend worldwide with colorectal and breast cancers as the leading cause of cancer deaths amounting to 9.2% and 6.6% of total cancer deaths, respectively [1]
Malnutrition is associated with higher adverse surgical outcomes, higher rate of toxicities during adjuvant therapies, decreased performance status, and worse disease prognosis among surgical cancer patients [5,6,7]
Objectives of the study {7} The primary objective of this study is to evaluate the impact of perioperative oral nutrition supplementation on nutritional outcomes among patients with primary breast and colorectal cancer and who are mildly malnourished
Summary
Background and rationale {6a} The incidence of cancer is on an increasing trend worldwide with colorectal and breast cancers as the leading cause of cancer deaths amounting to 9.2% and 6.6% of total cancer deaths, respectively [1]. The nutrition status of patients undergoing surgery for cancer can impact prognosis. You are invited to participate in a research study because you are malnourished cancer patient who will be undergoing elective surgery that requires nutrition intervention. 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
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