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

Phase 1

Completed

• Conditions: Acute non-infectious radiation cystitis; Prostate Cancer; Renal and Urogenital - Other renal and urogenital disorders; Cancer - Prostate

• Registration Number: ACTRN12611000887976
• Lead Sponsor: Creative Energy LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if cranberry capsules reduce the severity of cystitis.<br>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.[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 Measures

Name	Time	Method
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.[End of the trial when all the capsules have been used up.];To determine if cranberry capsules increase the time and dose to onset of cystitis[Time and dose to onset of cystitis];To determine if cranberry capsules decrease the need for symptom relief (ural).[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.]