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Diindolylmethane in Treating Patients With Abnormal Cervical Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462813
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Precancerous Condition Drug: oral microencapsulated diindolylmethane Genetic: polymerase chain reaction Other: cervical Papanicolaou test Other: cytology specimen collection procedure Procedure: colposcopic biopsy Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]
Study Start Date : October 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462813

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United Kingdom
Barts and the London School of Medicine
London, England, United Kingdom, EC1M 6BQ
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Barts and the London School of Medicine and Dentistry
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Study Chair: Peter Sasieni, MD Barts and the London School of Medicine and Dentistry

Additional Information:
Layout table for additonal information Identifier: NCT00462813     History of Changes
Other Study ID Numbers: CRUK-CRISP-1
CDR0000539352 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: September 2008
Keywords provided by National Cancer Institute (NCI):
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
cervical intraepithelial neoplasia grade 1
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents