Folic Acid Clinical Trial for the Prevention of Cervical Cancer

Phase 2

Completed

• Conditions: Cervical Cancer; Precancerous Condition
• Interventions: Dietary Supplement: folic acid; Other: placebo

• Registration Number: NCT00703196
• Lead Sponsor: University of Alabama at Birmingham

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.

OUTLINE: This is a single center study. Patients are stratified according to multivitamin use (yes vs no) and smoking status (smoker vs nonsmoker). Patients are randomized to 1 of 2 treatment arms.

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

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

All patients complete a diet, physical activity, and a risk factor questionnaire at the enrollment visit (0-month) and at 4, 8, and 12 month visits (a total of 4 visits). Fasting blood samples for assessing circulating concentrations of micronutrients (folate, vitamins B12, A, E, C, and total carotenes) and exfoliated cervical cell samples for assessing HPV are collected at all 4 visits. Anthropometric measures are taken at all study visits. A colposcopically directed biopsy is taken at the 0-month visit and at the 12-month visit to assess the histological diagnoses of cervical lesions.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Status Verified: 2014-01
• Primary Completion: 2014-05
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 368

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	folic acid	Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
Arm II	placebo	Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.

Primary Outcome Measures

Name	Time	Method
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2	One Year

Trial Locations

Locations (1)

UAB Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States