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) |
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| 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. |
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| Overall Status | Completed | ||||
| Start Date | 2007-03-01 | ||||
| Primary Completion Date | 2014-05-01 | ||||
| Phase | Phase 2 | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Enrollment | 368 |
| Condition | |
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| 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 |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
2014-01-01 |
| Responsible Party |
Type: Sponsor |
| Keywords |
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| 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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