Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

NCT ID: NCT00212381

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2010-07-31

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

Conditions

Cervical Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

oral DIM (Active agent)

2mg/kg/day po of DIM

Group Type: EXPERIMENTAL

di indolylmethane (DIM)

Intervention Type: DRUG

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

Red rice bran (Placebo)

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

Group Type: ACTIVE_COMPARATOR

Red rice bran

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

di indolylmethane (DIM)

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

Intervention Type: DRUG

Red rice bran

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Del Priore

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_DIRECTOR

NY Downtown Hospital

Alan Arslan, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19939441 (View on PubMed)

Other Identifiers

9218

Identifier Type: -

Identifier Source: org_study_id

NCT00206804

Identifier Type: -

Identifier Source: nct_alias