Condition category
Cancer
Date applied
31/08/2005
Date assigned
16/09/2005
Last edited
25/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.crukctuglasgow.org/

Contact information

Type

Scientific

Primary contact

Mrs Cathy Hutchison

ORCID ID

Contact details

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

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 measures

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

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

http://www.ngt.org.uk/research/home.htm

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21703829

Publication citations

  1. 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.

Additional files

Editorial Notes