To prep or not to prep - that is the question: A randomized trial on the use of antiflatulent medication as part of bowel preparation for patients having image guided external beam radiation therapy to the prostate.

INTRODUCTION: Radiation therapy is a standard treatment option for prostate cancer. With growing use of escalated doses and tighter margins, procedures to limit rectal size variation are needed to reduce prostate motion, increase treatment accuracy, and minimize rectal toxicity. This prospective study was done to determine whether the introduction of an antiflatulent medication would decrease rectal distention at computed tomography (CT) simulation and throughout a course of radiation therapy. METHODS AND MATERIALS: Patients undergoing a radical course of radiation therapy to the prostate/prostate bed were eligible to participate. Participants were randomly assigned to the intervention arm (antiflatulent medication) or the control arm (no medication). For each participant, the number of CT simulation rescans was recorded. Rectal diameters were measured on CT simulation and treatment cone beam CT scans. Acute rectal toxicities were assessed at baseline and weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. A χ2 analysis was used to compare the number of participants requiring a rescan in each study arm. Change in rectal diameter over time was assessed using repeated measures analysis of variance.
RESULTS: A total of 78 patients participated, with equal numbers assigned to each study arm. There was no significant difference between arms in the number of participants requiring a CT simulation rescan (P = .5551). There was no significant variation in rectal diameter between arms (P = .8999); however, there was a significant effect of time (P = .0017) and a significant interaction effect between study arm and time on rectal diameter (P = .0141). No acute rectal toxicities above grade 2 were reported.
CONCLUSIONS: The addition of antiflatulent medication did not affect the frequency of CT simulation rescans. Both time and the interaction between study arm and time had a statistically significant effect on rectal diameter, although neither finding was clinically significant. Instead, standardized bowel preparation education developed for this study may have been sufficient to limit rectal size variation.

RCT Entities:   Population Interventions Outcomes