Folic Acid Clinical Trial for the Prevention of Cervical Cancer

Overview

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.

Full Title of Study: “HPV Clearance by Folic Acid Supplementation (FACT for HPV)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2014

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.

Interventions

  • Dietary Supplement: folic acid
    • Given orally once daily
  • Other: placebo
    • Given orally once daily

Arms, Groups and Cohorts

  • Experimental: Arm I
    • Patients receive oral folic acid pill once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
  • Placebo Comparator: Arm II
    • Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.

Clinical Trial Outcome Measures

Primary Measures

  • Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
    • Time Frame: One Year

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chandrika J. Piyathilake, PhD, MPH, Study Chair, University of Alabama at Birmingham

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