None listed
Conditions
Brief summary
Radiation-induced cystitis is a common acute side effect of radiation therapy for prostate cancer, with no effective treatment. Because radiation cystitis is caused by free radical damage to the bladder lining, anti-oxidants, such as cranberry products, may decrease radiation cystitis severity. Our previous pilot study found that highly standardized cranberry capsules decreased the number of men experiencing radiation cystitis and that these men experienced pain/burning less frequently. Standard scales (such as RTOG) only distinguish 5 levels of severity from mild (1) to death (5) and are not sensitive enough to measure small differences in severity in mild-moderate cystitis. Non-invasive interventions such as cranberry capsules are not expected to affect the outcome of patients with grade 4-5 cystitis but may be able to decrease the severity of symptoms of mild to moderate cystitis. I therefore designed a new scale (RICAS: radiation induced cystitis assessment scale), which consists of 9 severity items of importance to men (based on our pilot) and the effect each of these has on their day to day life. We will test both scales on 50 prostate cancer patients who will take 2 cranberry capsules and 50 prostate cancer patients who will take 2 placebo capsules each day for 10 weeks. This stage III double blinded placebo controlled trial is designed to answer 2 questions: 1: Are cranberry capsules better than placebo capsules in decreasing cystitis severity? 2: Is RICAS better than RTOG in evaluating cystitis severity?
Interventions
Patients randomized to the intervention arm will take two cranberry capsules once a day during breakfast from the first day of radiation therapy till 3 weeks after completion of radiation therapy.
Creative Energy LTD is a New Zealand company that will provide the unmarked bottles with cranberry capsules (containing 72mg PACs) each and unmarked bottles with placebo capsules containing colloidal silica, magnesium stearate, cellulose and gelatin. The capsules will be opaque, making them indistingu
Patients randomized to the intervention arm will take two cranberry capsules once a day during breakfast from the first day of radiation therapy till 3 weeks after completion of radiation therapy. Creative Energy LTD is a New Zealand company that will provide the unmarked bottles with cranberry capsules (containing 72mg PACs) each and unmarked bottles with placebo capsules containing colloidal silica, magnesium stearate, cellulose and gelatin. The capsules will be opaque, making them indistinguishable from the cranberry capsules. Patients will bring back bottle for counting on Monday of every week.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All men attending the Radiation Therapy Department in Dunedin Hospital who will receive radiation therapy for prostate cancer.
Exclusion criteria
previous RT to the pelvis distant metastatic disease allergy to cranberries history of kidney stones on warfarin medication
Outcome results
None listed