Diindolylmethane in Treating Patients With Abnormal Cervical Cells - Full Text View

Sponsored by:	Barts and the London School of Medicine and Dentistry
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00462813

Purpose

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	Intervention	Phase
Cervical Cancer Precancerous/Nonmalignant Condition	Drug: oral microencapsulated diindolylmethane Procedure: cervical Papanicolaou test Procedure: colposcopic biopsy Procedure: cytology specimen collection procedure Procedure: polymerase chain reaction	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in lesion size at 6 months [ Designated as safety issue: No ]
Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months [ Designated as safety issue: No ]
Change in cervical cytology at 6 months [ Designated as safety issue: No ]
CIN ≥ grade 3 on histology at 6 months [ Designated as safety issue: No ]
Long term follow-up (i.e., 7 years) [ Designated as safety issue: No ]
Migraine, premenstrual syndrome (PMS), menstruation, and body weight [ Designated as safety issue: No ]

Estimated Enrollment:	3000
Study Start Date:	October 2004
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462813

Locations

United Kingdom, England
Barts and the London School of Medicine	Recruiting
London, England, United Kingdom, EC1M 6BQ
Contact: Peter Sasieni, MD 44-20-7017-0260
United Kingdom, Wales
University Hospital of Wales	Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Alison Fiander, MD, BM, MSC, DM, FRCOG 44-29-2074-3235

Sponsors and Collaborators

Barts and the London School of Medicine and Dentistry

Investigators

Study Chair:

Peter Sasieni, MD

Barts and the London School of Medicine and Dentistry

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000539352, CRUK-CRISP-1, ISRCTN47437431, EU-20717
Study First Received:	April 18, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00462813
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
cervical intraepithelial neoplasia grade 1

Study placed in the following topic categories:

Precancerous Conditions
Cervical intraepithelial neoplasia
Carcinoma in Situ
Congenital Abnormalities

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009