NCT00703196已完成2 期
HPV Clearance by Folic Acid Supplementation (FACT for HPV)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm II
Placebo Comparator
Patients receive oral placebo once daily for 12 months in the absence of unacceptable toxicity or any other adverse effects.
干预措施: 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.
干预措施: folic acid (Dietary Supplement)
结局指标
主要结局
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2
时间窗: One Year
次要结局
未报告次要终点
研究者
研究点 (1)
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