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Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

Primary Purpose

Cervical Dysplasia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

di indolylmethane (DIM)

Red rice bran

About this trial

This is an interventional treatment trial for Cervical Dysplasia focused on measuring cervical dysplasia, diindolylmethane, pap smear

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

NYU School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

oral DIM (Active agent)

Red rice bran (Placebo)

Arm Description

2mg/kg/day po of DIM

this agent is not generally thought to be active but may be

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HPV colonization by commercial ELIZA test

To correlate the response to DIM with HPV colonization

Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20

To assess for any adverse effects of oral DIM in women

Full Information

NCT ID

NCT00212381

First Posted

September 13, 2005

Last Updated

March 27, 2017

Sponsor

New York Presbyterian Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00212381

Brief Title

Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2000 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York Presbyterian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Dysplasia

Keywords

cervical dysplasia, diindolylmethane, pap smear

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

randomized double blind intervention trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

central pharmacy dispenses based on sealed randomization table

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

oral DIM (Active agent)

Arm Type

Experimental

Arm Description

2mg/kg/day po of DIM

Arm Title

Red rice bran (Placebo)

Arm Type

Active Comparator

Arm Description

this agent is not generally thought to be active but may be

Intervention Type

Drug

Intervention Name(s)

di indolylmethane (DIM)

Intervention Description

This is the agent being studies. Similar agents have been reported to have potential activity.

Intervention Type

Dietary Supplement

Intervention Name(s)

Red rice bran

Intervention Description

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

Primary Outcome Measure Information:

Title

Measure the regression of CIN in women by cytology, colposcopy, and biopsy,

Description

To determine if oral DIM is effective in promoting the regression of CIN in women

Time Frame

3 months

Secondary Outcome Measure Information:

Title

HPV colonization by commercial ELIZA test

Description

To correlate the response to DIM with HPV colonization

Time Frame

3 months

Title

Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20

Description

To assess for any adverse effects of oral DIM in women

Time Frame

one year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Del Priore, M.D., M.P.H.

Organizational Affiliation

NY Downtown Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Alan Arslan, M.D.

Organizational Affiliation

NYU School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19939441

Citation

Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24.

Results Reference

result

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Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

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