Status:
COMPLETED
Diindolylmethane in Treating Patients With Abnormal Cervical Cells
Lead Sponsor:
Barts and the London School of Medicine and Dentistry
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical intraepithelial neoplasi...
Detailed Description
OBJECTIVES: * Compare the effect of diindolylmethane vs placebo in reducing the prevalence of histologically proven high-grade cervical intraepithelial neoplasia in patients with low-grade cervical c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- First mildly dyskaryotic Pap smear or a second borderline Pap smear taken within the Cervical Screening Wales program
- Patients under surveillance following treatment for high-grade cervical intraepithelial neoplasia are not eligible
- No clinical suspicion of a concurrent invasive cervical cancer
- PATIENT CHARACTERISTICS:
- No invasive cancer within the past 3 years
- No known HIV positivity
- Not pregnant or nursing
- Not planning to become pregnant within the next 6 months
- PRIOR CONCURRENT THERAPY:
- No concurrent immunosuppressive drugs, warfarin, or theophylline
- No concurrent proton pump inhibitor drugs for ulcer or reflux disease (i.e., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00462813
Start Date
October 1 2004
End Date
January 1 2010
Last Update
August 7 2013
Active Locations (2)
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1
Barts and the London School of Medicine
London, England, United Kingdom, EC1M 6BQ
2
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW