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Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Del Priore, New York Presbyterian Hospital
ClinicalTrials.gov Identifier:
NCT00212381
First received: September 13, 2005
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Cervical Dysplasia
Drug: di indolylmethane (DIM)
Dietary Supplement: Red rice bran
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized double blind intervention trial
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:
central pharmacy dispenses based on sealed randomization table
Primary Purpose: Treatment
Official Title: Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)

Resource links provided by NLM:


Further study details as provided by Giuseppe Del Priore, New York Presbyterian Hospital:

Primary Outcome Measures:
  • Measure the regression of CIN in women by cytology, colposcopy, and biopsy, [ Time Frame: 3 months ]
    To determine if oral DIM is effective in promoting the regression of CIN in women


Secondary Outcome Measures:
  • HPV colonization by commercial ELIZA test [ Time Frame: 3 months ]
    To correlate the response to DIM with HPV colonization

  • Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20 [ Time Frame: one year ]
    To assess for any adverse effects of oral DIM in women


Estimated Enrollment: 62
Study Start Date: September 2000
Study Completion Date: July 2010
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral DIM (Active agent)
2mg/kg/day po of DIM
Drug: di indolylmethane (DIM)
This is the agent being studies. Similar agents have been reported to have potential activity.
Active Comparator: Red rice bran (Placebo)
this agent is not generally thought to be active but may be
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212381

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York Presbyterian Hospital
Investigators
Study Director: Giuseppe Del Priore, M.D., M.P.H. NY Downtown Hospital
Principal Investigator: Alan Arslan, M.D. NYU School of Medicine
  More Information

Publications:
Responsible Party: Giuseppe Del Priore, Professor, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT00212381     History of Changes
Obsolete Identifiers: NCT00206804
Other Study ID Numbers: 9218
Study First Received: September 13, 2005
Last Updated: March 27, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giuseppe Del Priore, New York Presbyterian Hospital:
cervical dysplasia, diindolylmethane, pap smear

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 25, 2017