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Trial registered on ANZCTR


Registration number
ACTRN12615001311549
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
1/12/2015
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Date results information initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of cranberry capsules for radiation cystitis in prostate cancer patients
Scientific title
Efficacy of standardized cranberry capsules in the prevention and management of acute radiation cystitis using a novel assessment scale
Secondary ID [1] 287987 0
nil
Universal Trial Number (UTN)
URA/11/08/038
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
radiation cystitis 296863 0
prostate cancer 296864 0
Condition category
Condition code
Renal and Urogenital 297096 297096 0 0
Other renal and urogenital disorders
Cancer 297097 297097 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293325 0
Prevention
Comparator / control treatment
Patients randomized to the control arm will take two placebo capsules once a day during breakfast from the first day of radiation therapy till 3 weeks after completion of radiation therapy.

Placebo capsules will contain colloidal silica, magnesium stearate, cellulose and gelatin. The capsules will be opaque, making them indistinguishable from the cranberry capsules. They will be produced by teh same company that makes the cranberry capsules, Creative Energy LTD.
Control group
Placebo

Outcomes
Primary outcome [1] 296705 0
Severity of non-haemorrhagic radiation cystitis as measured by RICAS, modified RTOG and the O'Leary-Sant Symptom and Problem scales for Interstitial Cystitis (IC).
Timepoint [1] 296705 0
RICAS, modified RTOG and IC scores will be recorded weekly from baseline till three weeks after completion of radiation treatment.
Secondary outcome [1] 319143 0
Sensitivity of RICAS compared to the modified RTOG and IC in measuring the severity of non-haemorrhagic radiation cystitis.
Timepoint [1] 319143 0
RICAS, RTOG and IC scores are recorded weekly from baseline until three weeks after completion of radiation therapy.

Eligibility
Key inclusion criteria
All men attending the Radiation Therapy Department in Dunedin Hospital who will receive radiation therapy for prostate cancer.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
previous RT to the pelvis
distant metastatic disease
allergy to cranberries
history of kidney stones
on warfarin medication

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomized to either the cranberry arm or the placebo arm. The research radiation therapist will send a randomization request to the PI, Dr Herst who is an academic in Wellington and has no patient involvement. Dr Herst will do the randomizations based on computer-generated random numbers provided by the biostatistician of the University of Otago, Gordon Purdie. Both the patients and the research radiation therapist will be blinded to which arm the patient is on. The cranberry and placebo capsules have been manufactured by the same company and look exactly the same.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary objective: Severity of cystitis using RTOG, IC and RICAS.
The difference between cranberry and placebo for the average severity of cystitis using RTOG/IC will be compared to the difference between cranberry and placebo for average RICAS by comparing the Wilcoxon rank-sum test statistics for the two comparisons.

Based on our previous pilot study, we aim to recruit 100 patients, 50 in the cranberry arm and 50 in the placebo arm. Trial is powered to 80% to detect a statistically significant difference between cranberry and placebo arms (p<0.05) of cystitis incidence and RICAS impact items of pain, nocturia and strength of stream


Secondary objective: Sensitivity of RICAS, RTOG and IC scales.
The severity of non-hamorrhagic cystitis in cranberry and placebo groups will be compared with Wilcoxon rank-sum tests for the RTOG, IC and RICAS scoring systems.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7366 0
New Zealand
State/province [1] 7366 0
South Island, Dunedin
Country [2] 9292 0
New Zealand
State/province [2] 9292 0
North Island, Tauranga
Country [3] 10676 0
New Zealand
State/province [3] 10676 0
Auckland

Funding & Sponsors
Funding source category [1] 292450 0
University
Name [1] 292450 0
University of Otago
Address [1] 292450 0
PO Box 56,
Dunedin 9054,
New Zealand
Country [1] 292450 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56,
Dunedin 9054,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291145 0
None
Name [1] 291145 0
Address [1] 291145 0
Country [1] 291145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293909 0
Southern Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 293909 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 293909 0
New Zealand
Date submitted for ethics approval [1] 293909 0
11/11/2015
Approval date [1] 293909 0
24/11/2015
Ethics approval number [1] 293909 0
15/STH/217

Summary
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?


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61794 0
A/Prof Patries Herst
Address 61794 0
Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 61794 0
New Zealand
Phone 61794 0
+64-4-3855475
Fax 61794 0
+64-4-3855375
Email 61794 0
patries.herst@otago.ac.nz
Contact person for public queries
Name 61795 0
A/Prof Patries Herst
Address 61795 0
Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 61795 0
New Zealand
Phone 61795 0
+64-4-3855475
Fax 61795 0
+64-4-3855375
Email 61795 0
patries.herst@otago.ac.nz
Contact person for scientific queries
Name 61796 0
A/Prof Patries Herst
Address 61796 0
Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 61796 0
New Zealand
Phone 61796 0
+64-4-3855475
Fax 61796 0
+64-4-3855375
Email 61796 0
patries.herst@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect the anonymity pf patients
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3706 0
Ethical approval
Citation [1] 3706 0
Link [1] 3706 0
Email [1] 3706 0
Other [1] 3706 0
Type [2] 3707 0
Study protocol
Citation [2] 3707 0
Link [2] 3707 0
Email [2] 3707 0
Other [2] 3707 0
Type [3] 3708 0
Informed consent form
Citation [3] 3708 0
Link [3] 3708 0
Email [3] 3708 0
Other [3] 3708 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary