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Trial registered on ANZCTR

Registration number

ACTRN12611000887976

Ethics application status

Approved

Date submitted

18/08/2011

Date registered

19/08/2011

Date last updated

25/11/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of cranberry capsules on cystitis in men treated with radiation for prostate cancer

Scientific title

The efficacy of cranberry capsules in the prevention and management of acute radiation cystitis in men treated with radiation for prostate cancer

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1123-8135

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute non-infectious 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 who have given written informed consent will be randomized to to either the cranberry arm or the placebo arm by the PI, Dr Patries Herst. Each participant will be given a numbered brown glass bottle (patient 01 will have bottle 01 etc.) containing either 70 cranberry or 70 placebo capsules at the start of their RT treatment.

The participants will take one capsule a day during breakfast from the first day of treatment and continue until all the capsules have been taken (10 weeks).

Durning the trial, participants are not allowed to take foods, drinks or supplements containing cranberries, blueberries or blackberries and limit consumption of grapes and wine.

The cranberry capsules contain 72mg proanthocyanidins (PACs) each.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

The placebo control capsules. contain colloidal silica, magnesium stearate, cellulose and gelatin. All capsules will be opaque, making them indistinguishable from the cranberry capsules. Participants randomized to the control arm will follow exactly the same regimen as the patients randomized to the treatment arm but tale placebo capsules instead of cranberry capsules.

Control group

Placebo

Outcomes

Primary outcome [1]

To determine if cranberry capsules reduce the severity of cystitis.
This will be assessed using a slightly modified urinary domain of the Expanded Prostate Index Composite (EPIC) measure (Wei et al.Urology, 2000. 56(6): p. 899-905). This is a 2 page questionnaire that aks the men about different urinary symptoms and how much bother each of these are in their daily life using simple Likert scales. Symptoms include: pain/burning, blood in urine, use of ural and urinary control.

Timepoint [1]

The first assessment will be done before radiation therapy begins, then once a week for 10 weeks until there are no more capsules left.

Secondary outcome [1]

To determine if cranberry capsules decrease the incidence of cystitis.This will be assessed using a slightly modified urinary domain of the Expanded Prostate Index Composite (EPIC) measure (Wei et al.Urology, 2000. 56(6): p. 899-905). This is a 2 page questionnaire that aks the men about different urinary symptoms and how much bother each of these are in their daily life using simple Likert scales. Symptoms include: pain/burning, blood in urine, use of ural and urinary control.

Timepoint [1]

End of the trial when all the capsules have been used up.

Secondary outcome [2]

To determine if cranberry capsules increase the time and dose to onset of cystitis

Timepoint [2]

Time and dose to onset of cystitis

Secondary outcome [3]

To determine if cranberry capsules decrease the need for symptom relief (ural).

Timepoint [3]

This will be evaluated weekly with the modified EPIC scale. One question on the scale specifically asks how often the men have used ural in the previous week.

Eligibility

Key inclusion criteria

All men receiving radiation therapy for prostate cancer at the Department of Radiation Therapy in Dunedin Hospital.

Minimum age

No limit

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Men who have had previous RT to the pelvis, have systemic disease, anallergy to cranberries or a history of kidney stones are excluded from this trial.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization will be carried out by the PI, Dr Patries Herst, who is a senior lecturer at the University of Otago in Wellington, has no patient contact and is not involved in any aspects of the day to day running of the trial.

Bottles containing cranberry capsules and bottles containing placebo capsules will be allocated a number between 1 and 40 by the PI using computer-generated random numbers (provided by the biostatistician). Patients, clinicians and research assistants will be blinded with respect to the content of the capsules. Unblinding will occur after all data have been collected at the end of the trial, followed by an in depth data analysis by the PI.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random numbers provided by the University's biostatistician.

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

One group of patients will receive cranberry capsules, one will receive placebo capsules

Phase

Phase 1 / Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

EPIC scores were analysed with SAS v9.3 (SAS Institute Inc., Cary, NC). The mean and maximum scores were compared with non-parametric Wilcoxon rank-sum tests and analysis of variance on the ranked data [25] with adjustment for whether or not the symptom was present at baseline. Analysis of variance on the rank data with terms for study group and either whether the patient had baseline symptoms or whether they had the high or low hydration regimen, and their interactions, were used to assess the statistical significance of any differences between sub-groups. A p-value <0.05 was treated as being statistically significant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2011

Actual

7/08/2012

Date of last participant enrolment

Anticipated

11/02/2013

Actual

20/03/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Department of Radiation Therapy
PO Box 7343
Wellington South 6242
Wellington

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Creative Energy LTD

Address

Natural Health
Wingate Industrial Park
80-82 Eastern Hutt Road
Taita, Lower Hutt
Wellington 5019.

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Dunedin Public Hospital

Address [1]

Southern Blood and Cancer Centre
Private bag 1921
Dunedin 9054

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Upper South A Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
Level 4, Charles Luney Building
250 Oxford Terrace
Christchurch 8011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

02/08/2011

Approval date [1]

15/08/2011

Ethics approval number [1]

URA/11/08/038

Summary

Brief summary

The overarching aim of the proposed trial is to investigate whether or not cranberry capsules are superior to placebo control capsules in reducing the severity and incidence of acute radiation cystitis occurring in men with prostate cancer.

Background
Prostate cancer is the most common cancer among older men in developed countries. Cancer Statistics NZ reported that in 2008, 2798 non-Maori men were diagnosed with prostate cancer and 635 men (23%) died of this disease in that year. During that same year, 141 Maori men were diagnosed and 35 men (25%) died of the disease [1]. Treatment for prostate cancer can include surgery, radiation therapy and hormone therapy, depending on the stage, location, co-morbidities and patient preferences. Acute radiation-induced cystitis is a common side effect of radiation therapy to the pelvis, with up to 40% of men suffering from cystitis to some extent [2, 3]. Acute symptoms occur within weeks of radiation treatment and include urinary urgency, frequency, dysuria, and hematuria. Currently there is no effective treatment for radiation cystitis. Standard care for radiation cystitis in the Southern Blood and Cancer Service in Dunedin Hospital radiation cystitis is ural, a urinary alkalinizer which relieves symptoms but does not affect cystitis.

Because radiation cystitis is caused by free radical damage to the bladder lining [4], therapies that decrease the number of free radicals in the bladder may decrease its severity [5]. Proanthocyanidins (PACs), phytochemicals found in the North American cranberry, have dose dependent radical scavenging, anti-bacterial and anti-carcinogenic properties [6-11]. A recent Cochrane Review reported that cranberry juice reduces the incidence of recurrent infectious cystitis (urinary tract infections) in young women by inhibiting adhesion of pathogenic E.coli bacteria to the bladder wall [12, 13].

The effect of cranberries on radiation cystitis has so far not been investigated. This double blinded placebo controlled pilot study will investigate the effect of cranberry capsules on the severity and incidence of acute radiation cystitis in men with prostate cancer. A shortened modified version of the Expanded Prostate Index Composite (EPIC) measure [14] will be used to assess the extent of cystitis 

References
1.	MOH, Cancer Statistics New Zealand. New Zealand Ministry of Health, 2010.
2.	McCammon et al. Int. J. Radiat. Oncol. Biol. Phys., 2009. 75(2): p. 413-420.
3.	Pervez et al. Int. J. Radiat. Oncol. Biol. Phys., 2010. 76(1): p. 57-64.
4.	Suresh et al.  J. Clin. Pathol., 1993. 46(3): p. 228-231.
5.	Greenberger, and Epperly. In Vivo, 2007. 21(2): p. 141-146.
6.	Côté et al. Crit. Rev. Food. Sci. Nutr. , 2010. 50(7): p. 666-679.
7.	Déziel et al. J. Cell. Biochem. , 2010. 111(3): p. 742-754.
8.	Menghini et al. J. Biol. Regul. Homeost. Agents, 2011. 25(1): p. 27-35.
9.	Pappas and Schaich. Critical Reviews in Food Science and Nutrition, 2009. 49: p. 741-781.
10.	Seeram. J. Agric. Food Chem., 2008. 56: p. 627-629.
11.	Seeram et al. J. Agric. Food Chem., 2004. 52: p. 2512-2517.
12.	Jepson and Craig. Cochrane Database Syst. Rev., 2008. 23(1): p. CD001321.
13.	Howell et al. BMC Infectious Diseases, 2010. 10: p. 94-105.
14.	Wei et al. Urology, 2000. 56(6): p. 899-905.

Trial website

Trial related presentations / publications

Hamilton, K.A., Bennett, N.C., Purdie, G.L., Herst, P.M. Standardized cranberry capsules for radiation cystitis in prostate cancer patients in New Zealand: a randomized double blinded placebo controlled pilot study. Supportive Care in Cancer, Support Care Cancer. 2015 Jan;23(1):95-102. doi: 10.1007/s00520-014-2335-8. Epub 2014 Jul 4.

Public notes

Attachments [1]

/AnzctrAttachments/343363-Hamilton, 2014.pdf

Contacts

Principal investigator

Name

Dr Patries Herst

Address

Senior Lecturer Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242 Wellington

Country

New Zealand

Phone

+64-4-3855475

Fax

+64-4-3855375

patries.herst@otago.ac.nz

Contact person for public queries

Name

Dr Patries Herst

Address

Senior Lecturer
Department of Radiation Therapy
University of Otago, Wellington
POBox 7343
Wellington South 6242
Wellington

Country

New Zealand

Phone

+64-4-3855475

Fax

+64-4-3855375

patries.herst@otago.ac.nz

Contact person for scientific queries

Name

Dr Patries Herst

Address

Senior Lecturer
Department of Radiation Therapy
University of Otago, Wellington
POBox 7343
Wellington South 6242
Wellington

Country

New Zealand

Phone

+64-4-3855475

Fax

+64-4-3855375

patries.herst@otago.ac.nz

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No Supporting Document Provided

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