Trial Information

An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]

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 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.