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

ISRCTN	ISRCTN44646348
DOI	https://doi.org/10.1186/ISRCTN44646348
Secondary identifying numbers	MI43

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Cathy Hutchison
Scientific

North Glasgow University Hospitals NHS Trust
Divisional Offices (West)
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

Study design	Randomised double blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	To assess whether drinking cranberry juice decreases the incidence of urinary tract infections and urinary side effects
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bladder or cervix cancer
Intervention	Cranberry juice or placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cranberry juice or placebo
Primary outcome measure	Increase in Common Toxicity Criteria (CTC) grade of urinary tract symptoms OR development of urinary tract infection
Secondary outcome measures	Other CTC toxicities
Overall study start date	24/02/2003
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	250
Key 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.
Key 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.
Date of first enrolment	24/02/2003
Date of final enrolment	01/01/2008

North Glasgow University Hospitals NHS Trust

Glasgow
G11 6NT
United Kingdom

Greater Glasgow NHS Board, North Glasgow Division (UK)
Hospital/treatment centre

West Research Office
Administration Building
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom

Website	http://www.ngt.org.uk/research/home.htm
"ROR"	https://ror.org/05kdz4d87

Charity

Western Endowment Fund (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2012		Yes	No