Diindolylmethane in Treating Patients With Abnormal Cervical Cells
NCT ID: NCT00462813
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3000 participants
INTERVENTIONAL
2004-10-31
2010-01-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it works compared to a placebo in treating patients with abnormal cervical cells.
Detailed Description
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* 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 cytological abnormalities.
* Compare the effect of these regimens in reducing the prevalence of cytological abnormalities in these patients.
* Compare the effect of these regimens in changing the clinical appearance of the cervix in these patients.
* Determine if diindolylmethane offers benefits in relation to human papillomavirus (HPV) status, including HPV type, viral load, and integration.
* Determine the side effects of supplementation with diindolylmethane.
* Determine the effects of this drug on migraine, mastalgia, weight, and premenstrual syndrome (PMS).
OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral diindolylmethane once daily for 6 months.
* Arm II: Patients receive oral placebo once daily for 6 months. Patients undergo cervical sampling at baseline and at 6 months for Pap testing by liquid based cytology and human papillomavirus (HPV) testing by polymerase chain reaction. Some patients also undergo urine and hair sample collection at baseline and at 3 and 6 months. Samples are analyzed for estrogen and diindolylmethane metabolites, to monitor patient compliance and response to treatment. Some patients have a cervical photograph taken using a colposcope at baseline and at 6 months. All patients undergo colposcopy at 6 months.
Patients complete a questionnaire at baseline (i.e., for reproductive history, diet, smoking, and premenstrual symptoms) and at 6 months (i.e., for side effects, compliance, changes in smoking, and contraception use). Patients with moderate to severe premenstrual syndrome (PMS) also complete PMS questionnaires once monthly during months 1-6 and 4 months following completion of study therapy. All patients are instructed to maintain current diet and to keep cruciferous vegetables and soy products constant during study course.
After completion of study treatment, patients are followed periodically for up to 7 years.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
DOUBLE
Interventions
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oral microencapsulated diindolylmethane
polymerase chain reaction
cervical Papanicolaou test
cytology specimen collection procedure
colposcopic biopsy
Eligibility Criteria
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Inclusion Criteria
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)
FEMALE
No
Sponsors
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Barts and the London School of Medicine and Dentistry
OTHER
Principal Investigators
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Peter Sasieni, MD
Role: STUDY_CHAIR
Barts and the London School of Medicine and Dentistry
Locations
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Barts and the London School of Medicine
London, England, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Countries
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Related Links
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Effect of diindolylmethane supplementation on low-grade cervical cytological abnormalities: double-blind, randomised, controlled trial. Br J Cancer. 2012 Jan 3;106(1):45-52. doi: 10.1038/bjc.2011.496. Epub 2011 Nov 10.
Other Identifiers
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CDR0000539352
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN47437431
Identifier Type: -
Identifier Source: secondary_id
EU-20717
Identifier Type: -
Identifier Source: secondary_id
CRUK-CRISP-1
Identifier Type: -
Identifier Source: org_study_id