NCT00462813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 7, 2013

Status Verified

September 1, 2008

Enrollment Period

3.7 years

First QC Date

April 18, 2007

Last Update Submit

August 6, 2013

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancercervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3cervical intraepithelial neoplasia grade 1

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Interventions

oral microencapsulated diindolylmethaneDRUG
polymerase chain reactionGENETIC
cervical Papanicolaou testOTHER
cytology specimen collection procedureOTHER
colposcopic biopsyPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Barts and the London School of Medicine

London, England, EC1M 6BQ, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

Interventions

Polymerase Chain ReactionVaginal Smears

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, Obstetrical and GynecologicalSurgical Procedures, Operative

Study Officials

  • Peter Sasieni, MD

    Barts and the London School of Medicine and Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

October 1, 2004

Primary Completion

June 1, 2008

Study Completion

January 1, 2010

Last Updated

August 7, 2013

Record last verified: 2008-09

Locations

GB(2)