Diindolylmethane in Treating Patients With Abnormal Cervical Cells

August 6, 2013 updated by: Barts and the London School of Medicine and Dentistry

An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical intraepithelial neoplasia or cervical cancer from forming.

PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it works compared to a placebo in treating patients with abnormal cervical cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the effect of diindolylmethane vs placebo in reducing the prevalence of histologically proven high-grade cervical intraepithelial neoplasia in patients with low-grade cervical cytological abnormalities.
  • Compare the effect of these regimens in reducing the prevalence of cytological abnormalities in these patients.
  • Compare the effect of these regimens in changing the clinical appearance of the cervix in these patients.
  • Determine if diindolylmethane offers benefits in relation to human papillomavirus (HPV) status, including HPV type, viral load, and integration.
  • Determine the side effects of supplementation with diindolylmethane.
  • Determine the effects of this drug on migraine, mastalgia, weight, and premenstrual syndrome (PMS).

OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral diindolylmethane once daily for 6 months.
  • Arm II: Patients receive oral placebo once daily for 6 months. Patients undergo cervical sampling at baseline and at 6 months for Pap testing by liquid based cytology and human papillomavirus (HPV) testing by polymerase chain reaction. Some patients also undergo urine and hair sample collection at baseline and at 3 and 6 months. Samples are analyzed for estrogen and diindolylmethane metabolites, to monitor patient compliance and response to treatment. Some patients have a cervical photograph taken using a colposcope at baseline and at 6 months. All patients undergo colposcopy at 6 months.

Patients complete a questionnaire at baseline (i.e., for reproductive history, diet, smoking, and premenstrual symptoms) and at 6 months (i.e., for side effects, compliance, changes in smoking, and contraception use). Patients with moderate to severe premenstrual syndrome (PMS) also complete PMS questionnaires once monthly during months 1-6 and 4 months following completion of study therapy. All patients are instructed to maintain current diet and to keep cruciferous vegetables and soy products constant during study course.

After completion of study treatment, patients are followed periodically for up to 7 years.

PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, EC1M 6BQ
        • Barts and the London School of Medicine
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • First mildly dyskaryotic Pap smear or a second borderline Pap smear taken within the Cervical Screening Wales program

    • Patients under surveillance following treatment for high-grade cervical intraepithelial neoplasia are not eligible
  • No clinical suspicion of a concurrent invasive cervical cancer

PATIENT CHARACTERISTICS:

  • No invasive cancer within the past 3 years
  • No known HIV positivity
  • Not pregnant or nursing
  • Not planning to become pregnant within the next 6 months

PRIOR CONCURRENT THERAPY:

  • No concurrent immunosuppressive drugs, warfarin, or theophylline
  • No concurrent proton pump inhibitor drugs for ulcer or reflux disease (i.e., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months

Secondary Outcome Measures

Outcome Measure
Change in lesion size at 6 months
Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months
Change in cervical cytology at 6 months
CIN ≥ grade 3 on histology at 6 months
Long term follow-up (i.e., 7 years)
Migraine, premenstrual syndrome (PMS), menstruation, and body weight

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts and the London School of Medicine and Dentistry

Investigators

  • Study Chair: Peter Sasieni, MD, Barts and The London School of Medicine and Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-CRISP-1
  • CDR0000539352 (Registry Identifier: PDQ (Physician Data Query))
  • ISRCTN47437431
  • EU-20717

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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