Achieving an empty rectum for prostate radiation therapy: comparison of two laxative treatment.
Phase 4
Completed
- Conditions
- Prostate cancerCancer - Prostate
- Registration Number
- ACTRN12616000728437
- Lead Sponsor
- icole Weston
- Brief Summary
This study has demonstrated that an osmotic laxative is more effective than a bulking laxative and probiotic at achieving low rectal gas levels during radiation treatment for prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 17
Inclusion Criteria
Adult patients fifty years of age or older undergoing external bean radiotherapy (EBRT) to the intact prostate, using fiducial markers for position verification.
Exclusion Criteria
Severe constipation, abdominal disease (Crohn’s disease, ulcerative colitis, irritable bowel syndrome), history of extensive abdominal surgery, patients using digoxin or salicylates. Individuals whose primary language is other than English.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in rectal volume between the two treatment arms, <br>CT scans are routinely conducted during treatment with a total of 12 collected over the treatment period. Rectal volume will be measured by outlining the prostate, bladder and rectum on all CBCT scans. The rectal volume and cross sectional area will be recorded from this data[Baseline, daily during the first week of treatment and at weekly intervals over a 7 week period while receiving radiation therapy.]; Differences in rectal gas measurements between the two treatment arms, <br>Rectal gas which will be estimated by viewing the CT scan in the mid-sagittal plane and using a semi quantitative scale of 1-5; representing (1)no gas present, (2) gas occupying 5 to less than 25%, (3) 25 t less than 50%, (4) 50 less than 75% and (5) 75 less than 100% of the rectum.[Baseline, daily during the first week of treatment and at weekly intervals over a 7 week period while receiving radiation therapy.]
- Secondary Outcome Measures
Name Time Method The number of patients with symptoms of diarrhoea during treatment requiring the cessation of laxatives. This will be assessed at weekly review appointments using the patient self-reported diary which includes the Bristol stool chart.[At baseline and weekly over a 7 week period while receiving radiation therapy]