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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44646348
Enrollment
250
Registered
2005-09-16
Start date
2003-02-24
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder or cervix cancer Cancer 1. Malignant neoplasm of bladder 2. Maligant neoplasm of cervix uteri

Interventions

Cranberry juice or placebo

Sponsors

Greater Glasgow NHS Board, North Glasgow Division (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Increase in Common Toxicity Criteria (CTC) grade of urinary tract symptoms OR development of urinary tract infection

Secondary

MeasureTime frame
Other CTC toxicities

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026