None listed
Conditions
Brief summary
This study will evaluate the effect of a drug called Simethicone versus no bowel preparation on rectal volume and side effects in men undergoing radiotherapy for their prostate. Who is it for? You may be eligible to join this study if you are male aged greater than 18 who is scheduled to receive external beam radiotherapy (ERBT) to the prostate. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group take an anti-flatulent medication, called Simethicone, 3 days prior to their planning CT scan, and then throughout radiotherapy treatment. Simethicone is administered as an oral capsule three times a day. Participants in the other group will receive treatment as usual without medical means of bowel preparation. All participants will undergo weekly Cone Beam CT scans throughout the 7 weeks of radiotherapy, in order to evaluate rectal volume and volume of gas in the rectum. They will also be asked to complete questionnaires to evaluate any radiotherapy side effects. It is hoped that this research will contribute to the further improvement of the accuracy of radiation treatment to prostate cancer patients.
Interventions
Intervention:
Simethicone: An anti-flatulent medication which is a mixture of liquid dimeticones that contain finely divided silicon dioxide which acts as a defoaming agent by reducing the surface tension of mucus. This allows entrapped air bubbles to coalesce, disperse and hence aids in the expulsion of intestinal air. (MedicinesComplete)
Arm 1 will commence Simethicone 3 days before their planning CT to prepare for radiotherapy and continue this for 3 days, 1 capsule (100mg) three times a da
Intervention: Simethicone: An anti-flatulent medication which is a mixture of liquid dimeticones that contain finely divided silicon dioxide which acts as a defoaming agent by reducing the surface tension of mucus. This allows entrapped air bubbles to coalesce, disperse and hence aids in the expulsion of intestinal air. (MedicinesComplete) Arm 1 will commence Simethicone 3 days before their planning CT to prepare for radiotherapy and continue this for 3 days, 1 capsule (100mg) three times a day. They can then stop taking it and restart it 3 days before radiotherapy commences (same dosing as above) and stop at the end of radiotherapy. The aim is to see if this reduces rectal volumes to allow more geographic accuracy of radiotherapy to the intended target in prostate cancer patients. Arm 2 will be the non-intervention arm Intervention adherence: Each patient will receive a phone call reminder 1 day prior to taking the first dose of simethicone. This will mean each patient gets two phone calls: One prior to taking the pre-planning day course of simethicone, and one prior to taking the pre-treatment course of simethicone. At each doctor review (at planning and weekly during treatment) there will be a specific form to be filled out regarding whether compliance has been achieved.
Sponsors
Radiation Oncology Department, Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients receiving external beam radiotherapy (ERBT) to the prostate or post-prostatectomy bed +/- pelvic lymph nodes in both cases. • Age >18 years • Receiving 6 or more weeks of radiotherapy treatment. • Life expectancy of at least 12 months • Written informed consent for entry into the study.
Exclusion criteria
• History of previous surgery to the bowel. • Inflammatory bowel disease. • Patients taking levothyroxine - Simethicone given regularly may decrease levothyroxine absorption.
Outcome results
None listed