Perioperative optimization with nutritional supplements in patients undergoing gastrointestinal surgery for cancer: A randomized, placebo-controlled feasibility clinical trial.

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.

Randomized trial of decongestive lymphatic therapy for the treatment of lymphedema in women with breast cancer.

PURPOSE: Because of its morbidity and chronicity, arm lymphedema remains a concerning complication of breast cancer treatment. Although massage-based decongestive therapy is often recommended, randomized trials have not consistently demonstrated benefit over more conservative measures. PATIENTS AND METHODS: Women previously treated for breast cancer with lymphedema were enrolled from six institutions. Volumes were calculated from circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily manual lymphatic drainage and bandaging followed by compression garments (experimental). The primary outcome was percent reduction in excess arm volume from baseline to 6 weeks. RESULTS: A total of 103 women were randomly assigned, and 95 were evaluable. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% CI, -6.8% to 20.5%; P = .34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI, 13 to 203 mL; P = .03). There was no difference between groups in the proportion of patients losing 50% or greater excess arm volume. Quality of life (Short Form-36 Health Survey) and arm function were not different between groups. CONCLUSION: This trial was unable to demonstrate a significant improvement in lymphedema with decongestive therapy compared with a more conservative approach. The failure to detect a difference may have been a result of the relatively small size of our trial.