Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MI43
Study information
Scientific title
Acronym
Study hypothesis
To assess whether drinking cranberry juice decreases the incidence of urinary tract infections and urinary side effects
Ethics approval
Not provided at time of registration
Study design
Randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bladder or cervix cancer
Intervention
Cranberry juice or placebo
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
24/02/2003
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant 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.
Recruitment start date
24/02/2003
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Glasgow University Hospitals NHS Trust
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
Greater Glasgow NHS Board, North Glasgow Division (UK)
Sponsor details
West Research Office
Administration Building
Western Infirmary
Glasgow
G11 6NT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Western Endowment Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21703829
Publication citations
-
Results
Cowan CC, Hutchison C, Cole T, Barry SJ, Paul J, Reed NS, Russell JM, A randomised double-blind placebo-controlled trial to determine the effect of cranberry juice on decreasing the incidence of urinary symptoms and urinary tract infections in patients undergoing radiotherapy for cancer of the bladder or cervix., Clin Oncol (R Coll Radiol), 2012, 24, 2, e31-8, doi: 10.1016/j.clon.2011.05.009.