Folic Acid Clinical Trial for the Prevention of Cervical Cancer

HPV Clearance by Folic Acid Supplementation (FACT for HPV)

Sponsors

Lead Sponsor: University of Alabama at Birmingham

Collaborator: National Cancer Institute (NCI)

Source 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.

Overall Status Completed
Start Date 2007-03-01
Primary Completion Date 2014-05-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2 One Year
Enrollment 368
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: folic acid

Description: Given orally once daily

Arm Group Label: Arm I

Intervention Type: Other

Intervention Name: placebo

Description: Given orally once daily

Arm Group Label: Arm II

Eligibility

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

Gender:

Female

Minimum Age:

19 Years

Maximum Age:

120 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Chandrika J. Piyathilake, PhD, MPH Study Chair University of Alabama at Birmingham
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: UAB Comprehensive Cancer Center
Location Countries

United States

Verification Date

2014-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm I

Type: Experimental

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

Label: Arm II

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

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