Diindolylmethane in Treating Patients With Abnormal Cervical Cells
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 neoplasia or cervical cancer from forming.
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.
Drug: oral microencapsulated diindolylmethane
Genetic: polymerase chain reaction
Other: cervical Papanicolaou test
Other: cytology specimen collection procedure
Procedure: colposcopic biopsy
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]|
- Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months [ Designated as safety issue: No ]
- Change in lesion size at 6 months [ Designated as safety issue: No ]
- Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months [ Designated as safety issue: No ]
- Change in cervical cytology at 6 months [ Designated as safety issue: No ]
- CIN ≥ grade 3 on histology at 6 months [ Designated as safety issue: No ]
- Long term follow-up (i.e., 7 years) [ Designated as safety issue: No ]
- Migraine, premenstrual syndrome (PMS), menstruation, and body weight [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- 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.
|Barts and the London School of Medicine|
|London, England, United Kingdom, EC1M 6BQ|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Study Chair:||Peter Sasieni, MD||Barts and the London School of Medicine and Dentistry|