Abstract
Background
Perioperative nutritional supplementation may improve outcomes. Trials have not investigated
the role of combination strategy using different types of nutritional supplements.
Methods
We conducted a single-site randomized pilot trial, among gastrointestinal cancer patients
undergoing surgery, comparing perioperative nutritional supplements versus placebo
(1 placebo to each supplement), to determine feasibility of a larger trial. Intervention,
administered in sequence, included: protein supplementation (preoperative day 30–6),
protein supplementation rich in arginine and omega-6 (preoperative day 5–1, and postoperative
day 1–5), and carbohydrate loading (surgery day). Primary outcome was enrollment.
Secondary outcomes included participant compliance with study supplements (target
≥70% of total packets). We planned protocol modifications to improve enrollment and
compliance. Postoperative complications were described.
Results
Over 18 months, 495 patients were screened, 144 were deemed eligible, and 71 consented
to participate, resulting in an enrollment fraction of 71/144 (49%, 95% confidence
interval: 41%–57%). ‘Too much burden’ was the most common reason for refusal to participate
(34%). Participants’ median overall compliance with study packets was 80%. Protocol
modifications (decreasing the interval from enrollment to surgery from 4 to 2 weeks
and decreasing length of baseline assessment) did not impact enrollment or compliance.
Postoperative complications were similar between control (18/31 [58%, 95% confidence
interval: 4–74]), and intervention (22/34 [65%, 95% confidence interval: 48–79]) arms,
with a higher proportion of infectious complications in the control arm (16/31, 52%
vs 12/34, 35%).
Conclusion
Results from this pilot suggest a larger phase III trial is feasible. Postoperative
infectious complications were common, making this a suitable outcome of interest.
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Article info
Publication history
Published online: May 20, 2022
Accepted:
April 1,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
