A randomised double-blind study of the effect of cranberry juice in decreasing the incidence of urinary symptoms and urinary tract infections in patients undergoing pelvic radiotherapy for cancer of bladder or cervix

Completed

• Conditions: Bladder or cervix cancer; Cancer; 1. Malignant neoplasm of bladder2. Maligant neoplasm of cervix uteri

• Registration Number: ISRCTN44646348
• Lead Sponsor: Greater Glasgow NHS Board, North Glasgow Division (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Patients with cervical cancer about to start standard chemoradiation (weekly cisplatin chemotherapy plus radiation therapy as below) or radiation therapy (4300-4500 cGy over 20 fractions +/-selectron radiotherapy)
2. OR patients with bladder cancer about to commence standard radical radiotherapy (5000-5240 cGy over 20 fractions).
3. Age = 18 years.
4. ECOG performance status = 2.
5. Written informed consent and the ability to comply with the requirements of the study.

Exclusion Criteria

1. Pregnant or lactating women are excluded. Female patients of child-bearing potential are eligible provided they have a negative urine pregnancy test prior to enrolment and agree to use approved contraceptive precautions during the trial and for 6 months afterwards.
2. Patients with irritable bowel syndrome (they may experience episodes of diarrhoea as a side effect of drinking cranberry juice).
3. Patients who are diabetic (due to the high sugar content of the juice).
4. Patients who have rheumatoid arthritis (the acidic juices may exacerbate joint pain).
5. Patients with urinary symptoms or urinary tract infections at baseline.
6. Patients receiving antispasmodics or antibiotics for urinary symptoms.
7. Patients with an indwelling urinary catheter.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase inCommon Toxicity Criteria (CTC) grade of urinary tract symptoms OR development of urinary tract infection

Secondary Outcome Measures

Name	Time	Method
Other CTC toxicities