A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Active Comparator: Non-vegetarian N-111 group.
研究概览
简要总结
The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.
详细描述
The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active product (N-111) and placebo will be in identical packets with the contents of identical weight, color and texture.
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.
- •Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.
排除标准
- ••Patients without the positive diagnosis of breast or prostate cancer.
结局指标
主要结局
Active Comparator: Non-vegetarian N-111 group.
时间窗: End of month 3.
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Active Comparator: Vegetarian N-111 group
时间窗: End of month 3.
Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
次要结局
- Placebo Comparator: Non-vegetarian placebo control group(End of month 3.)
- Placebo Comparator: Vegetarian placebo group(End of month 3.)