Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

Study Overview
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Brief Summary
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To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.

Detailed Description
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To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation

Official Title
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Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)

Conditions
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Cervical Dysplasia

Intervention / Treatment
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* Drug: di indolylmethane (DIM)
* Dietary Supplement: Red rice bran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non pregnant women greater than or equal to 18 years of age able to consent CIN II or III confirmed by histology Karnofsky performance status >= 80 No prior treatment for dysplasia in the past 4 months Exclusion Criteria: Incompletely visible lesion Diethylstilbestrol (DES) exposure HIV seropositive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized double blind intervention trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral DIM (Active agent)<br>2mg/kg/day po of DIM | Drug: di indolylmethane (DIM)<br>* This is the agent being studies. Similar agents have been reported to have potential activity.<br>|
| Active Comparator: Red rice bran (Placebo)<br>this agent is not generally thought to be active but may be | Dietary Supplement: Red rice bran<br>* this will act as the active comparator. The sponsor provided this as the placebo arm since it is a filler component of their DIM capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the regression of CIN in women by cytology, colposcopy, and biopsy, | To determine if oral DIM is effective in promoting the regression of CIN in women | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV colonization by commercial ELIZA test | To correlate the response to DIM with HPV colonization | 3 months | 
| Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20 | To assess for any adverse effects of oral DIM in women | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical dysplasia, diindolylmethane, pap smear