Overview

Diindolylmethane in Treating Patients With Abnormal Cervical Cells

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barts and the London School of Medicine and Dentistry
Treatments:
3,3'-diindolylmethane
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)