A Phase 3 interventional study of oral microencapsulated diindolylmethane and polymerase chain reaction in Cervical Cancer and Precancerous Condition, sponsored by Barts and the London School of Medicine and Dentistry. Completed at 2 sites in United Kingdom. Open to female participants. Per ClinicalTrials.gov, last updated 2013-08-07.
Sponsored by Barts and the London School of Medicine and Dentistry · Phase 3, Interventional, and Prevention
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.
OBJECTIVES:
OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Barts and the London School of Medicine and Dentistry is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
First mildly dyskaryotic Pap smear or a second borderline Pap smear taken within the Cervical Screening Wales program
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months
Change in lesion size at 6 months
Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months
Change in cervical cytology at 6 months
CIN ≥ grade 3 on histology at 6 months
Long term follow-up (i.e., 7 years)
Migraine, premenstrual syndrome (PMS), menstruation, and body weight
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Barts and the London School of Medicine and Dentistry