An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 4
- 主要终点
- Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical intraepithelial neoplasia or cervical cancer from forming.
PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it works compared to a placebo in treating patients with abnormal cervical cells.
详细描述
OBJECTIVES:
- Compare the effect of diindolylmethane vs placebo in reducing the prevalence of histologically proven high-grade cervical intraepithelial neoplasia in patients with low-grade cervical cytological abnormalities.
- Compare the effect of these regimens in reducing the prevalence of cytological abnormalities in these patients.
- Compare the effect of these regimens in changing the clinical appearance of the cervix in these patients.
- Determine if diindolylmethane offers benefits in relation to human papillomavirus (HPV) status, including HPV type, viral load, and integration.
- Determine the side effects of supplementation with diindolylmethane.
- Determine the effects of this drug on migraine, mastalgia, weight, and premenstrual syndrome (PMS).
OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral diindolylmethane once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Patients undergo cervical sampling at baseline and at 6 months for Pap testing by liquid based cytology and human papillomavirus (HPV) testing by polymerase chain reaction. Some patients also undergo urine and hair sample collection at baseline and at 3 and 6 months. Samples are analyzed for estrogen and diindolylmethane metabolites, to monitor patient compliance and response to treatment. Some patients have a cervical photograph taken using a colposcope at baseline and at 6 months. All patients undergo colposcopy at 6 months.
Patients complete a questionnaire at baseline (i.e., for reproductive history, diet, smoking, and premenstrual symptoms) and at 6 months (i.e., for side effects, compliance, changes in smoking, and contraception use). Patients with moderate to severe premenstrual syndrome (PMS) also complete PMS questionnaires once monthly during months 1-6 and 4 months following completion of study therapy. All patients are instructed to maintain current diet and to keep cruciferous vegetables and soy products constant during study course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •First mildly dyskaryotic Pap smear or a second borderline Pap smear taken within the Cervical Screening Wales program
- •Patients under surveillance following treatment for high-grade cervical intraepithelial neoplasia are not eligible
- •No clinical suspicion of a concurrent invasive cervical cancer
- •PATIENT CHARACTERISTICS:
- •No invasive cancer within the past 3 years
- •No known HIV positivity
- •Not pregnant or nursing
- •Not planning to become pregnant within the next 6 months
- •PRIOR CONCURRENT THERAPY:
- •No concurrent immunosuppressive drugs, warfarin, or theophylline
- •No concurrent proton pump inhibitor drugs for ulcer or reflux disease (i.e., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
排除标准
- 未提供
结局指标
主要结局
Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months
次要结局
- Change in lesion size at 6 months
- Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months
- Change in cervical cytology at 6 months
- CIN ≥ grade 3 on histology at 6 months
- Long term follow-up (i.e., 7 years)
- Migraine, premenstrual syndrome (PMS), menstruation, and body weight