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Clinical Trials/NCT00703196
NCT00703196CompletedPhase 2

HPV Clearance by Folic Acid Supplementation (FACT for HPV)

University of Alabama at Birmingham1 site in 1 country368 target enrollmentStarted: March 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
368
Locations
1
Primary Endpoint
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the effects of folic acid supplementation on clearance of human papilloma virus (HPV) 16 and other specific types of HR-HPV and on prevention of the progression of ≤ cervical intraepithelial neoplasia (CIN) 1 lesions (not true preneoplastic lesions) to CIN ≥ 2 (true neoplastic lesions) by conducting a 12-month double-blind randomized placebo-controlled trial with 5 mg of folic acid/day.

Secondary

  • Evaluate whether the clearance of HPV 16 and other specific HR-HPV types and the progression of cervical lesions (≤ CIN 1 to CIN ≥ 2) is modified by lower levels of circulating and/or cervical cell folate, presence of micronuclei or global DNA hypomethylation in cervical cells, presence of integrated vs episomal HPV 16, or a high HPV 16 viral load in cervical cells at the enrollment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to 120 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm II

Placebo Comparator

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

Intervention: placebo (Other)

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.

Intervention: folic acid (Dietary Supplement)

Outcomes

Primary Outcomes

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

Time Frame: One Year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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