Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212381
• Other study ID #: 9218
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 27, 2017
• Start date: September 2000
• Est. completion date: July 2010

Study information

• Verified date: March 2017
• Source: New York Presbyterian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Other known NCT identifiers

• NCT00206804

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2010
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Drug:
• di indolylmethane (DIM)
This is the agent being studies. Similar agents have been reported to have potential activity.

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HPV colonization by commercial ELIZA test	To correlate the response to DIM with HPV colonization	3 months
Secondary	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