NCT00703196

Brief Summary

RATIONALE: Supplements, such as folic acid, may stop or delay the development of cervical cancer in women infected with human papillomavirus. PURPOSE: This phase II trial is studying how well folic acid supplements work in preventing cancer in women infected with human papillomavirus.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
368

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

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

March 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

October 8, 2015

Status Verified

January 1, 2014

Enrollment Period

7.2 years

First QC Date

June 20, 2008

Last Update Submit

October 6, 2015

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancerhuman papilloma virus infectionlow-grade squamous intraepithelial lesionhigh-grade squamous intraepithelial lesionatypical squamous cells of undetermined significancecervical intraepithelial neoplasia grade 1cervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (1)

  • Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2

    One Year

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.

Dietary Supplement: folic acid

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.

Other: placebo

Interventions

folic acidDIETARY_SUPPLEMENT

Given orally once daily

Arm I
placeboOTHER

Given orally once daily

Arm II

Eligibility Criteria

Age19 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Received care at the Health Departments in Alabama and with an abnormal pap result, including any of the following: * Atypical squamous cells of undetermined significance (ASCUS) * ASCUS, cannot exclude high-grade lesion (ASCUS-H) * Low-grade squamous intraepithelial lesion * High-grade squamous intraepithelial lesion * Referred to University of Alabama at Birmingham (UAB) Highlands Clinic for further colposcopic examination by Ob/Gyn physicians * Tested positive for human papilloma virus (HPV) 16 and diagnosed with ≤ cervical intraepithelial neoplasia (CIN) 1 lesions at the 0-month visit * With or without concurrent infections with other HR (High Risk) HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) * Not diagnosed with true preneoplastic lesions of the cervix based on a colposcopically directed biopsy PATIENT CHARACTERISTICS: * Not pregnant * Willing to take study pills, keep scheduled follow-up study visits, or communicate with study personnel about changes in contact information during the study period * No prior diagnosis or treatment for colon polyps or breast lumps PRIOR CONCURRENT THERAPY: * No prior treatment for cervical cancer or precancerous condition * No prior surgeries involving the cervix * No concurrent antifolate medications such as methotrexate, sulfasalazine or phenytoin * No concurrent or planned consumption of 400 μg or more of a folic acid supplement on a regular basis * Not involved in any other clinical trial

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

Sponsors & Collaborators

Study Sites (1)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsPapillomavirus InfectionsSquamous Intraepithelial LesionsAtypical Squamous Cells of the CervixUterine Cervical Dysplasia

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMorphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Chandrika J. Piyathilake, PhD, MPH

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

March 1, 2007

Primary Completion

May 1, 2014

Last Updated

October 8, 2015

Record last verified: 2014-01

Locations

US(1)