ANZCTR - Registration

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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

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]

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

prostate cancer

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Cancer

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]

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]

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]

RICAS, modified RTOG and IC scores will be recorded weekly from baseline till three weeks after completion of radiation treatment.

Secondary outcome [1]

Sensitivity of RICAS compared to the modified RTOG and IC in measuring the severity of non-haemorrhagic radiation cystitis.

Timepoint [1]

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

Sex

Males

Can healthy volunteers participate?

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

1/02/2016

Actual

4/10/2016

Date of last participant enrolment

Anticipated

1/12/2018

Actual

21/12/2018

Date of last data collection

Anticipated

Actual

15/04/2019

Sample size

Target

120

Accrual to date

Final

110

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

South Island, Dunedin

Country [2]

New Zealand

State/province [2]

North Island, Tauranga

Country [3]

New Zealand

State/province [3]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO Box 56,
Dunedin 9054,
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee (HDEC)

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/11/2015

Approval date [1]

24/11/2015

Ethics approval number [1]

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

A/Prof Patries Herst

Address

Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country

New Zealand

Phone

+64-4-3855475

Fax

+64-4-3855375

[email protected]

Contact person for public queries

Name

Patries Herst

Address

Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country

New Zealand

Phone

+64-4-3855475

Fax

+64-4-3855375

[email protected]

Contact person for scientific queries

Name

Patries Herst

Address

Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343
Wellington South 6242

Country

New Zealand

Phone

+64-4-3855475

Fax

+64-4-3855375

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To protect the anonymity pf patients

What supporting documents are/will be available?

Doc. No.	Type	Attachment
3706	Ethical approval	369684-(Uploaded-02-08-2019-09-50-38)-Study-related document.pdf
3707	Study protocol	369684-(Uploaded-02-08-2019-09-52-11)-Study-related document.docx
3708	Informed consent form	369684-(Uploaded-02-08-2019-09-51-30)-Study-related document.doc

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.	2020	https://dx.doi.org/10.1016/j.radonc.2020.05.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically