Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Evidence of objective and quantifiable changes in thyroid size as a resalt of the oral administration of DIM, confirmed by pre- and post- DIM treatment ultrasounds
研究概览
简要总结
Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, & Brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. DIM has been shown to exert control over cancer cell growth in breast, uterine, cervical, ovarian, and colon cancer.
To date no human study has been published regarding the bioavailability of DIM in thyroid tissue or its effects in proliferative thyroid disease. Our previous study attempted to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively.
This study would continue our attempt to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.
排除标准
- •Patients who are pregnant, attempting to conceive, or lactating will be excluded due to possible deleterious effects of treatment on fetus/infant. Patients taking oral contraceptives, estrogen therapy, tamoxifin or those with a history of breast cancer will be excluded. Patients with liver disease and those taking statins for hypercholesterolemia will also be excluded to decrease the potential for possible liver toxicity. Any patient with elevated liver enzymes on pretreatment blood screening will be excluded from study participation. Patients with serious systemic diseases such as renal failure, diabetes, blood dyscrasia, coagulopathy, and non-optimized cardiopulmonary disease will be excluded due to the possibility of confounding blood tests screening for toxicity.
结局指标
主要结局
Evidence of objective and quantifiable changes in thyroid size as a resalt of the oral administration of DIM, confirmed by pre- and post- DIM treatment ultrasounds
时间窗: after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped
次要结局
- Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis(after 30 days of DIM consumption)
研究者
Stimpson P. Schantz
Principal Investigator
The New York Eye & Ear Infirmary