Alleviating Androgen Deprivation Therapy (ADT) + External Beam Radiation (EBR) Treatment Side Effects in Prostate Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Self-reporting
研究概览
简要总结
Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?
详细描述
Researchers will compare nutraceutical N-111 to a placebo (a look-alike substance that contains no active ingredients) and control group to see if N-111 works to alleviate side effects of prostate cancer treatment.
Participants will:
Take N-111 or a placebo by mouth every day for the duration of the ADT + EBR therapy. Fill out the self-evaluation reporting form weekly during EBR therapy and every three months during ADT therapy to assess their symptoms or lack of symptoms.
The patients will see a physician once a week during the EBR therapy and once every three months for the duration of the ADT therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both the active compactor and the placebo will be in unlabeled foil packets. The contents will be the same weight and color.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male undergoing treatment for prostate cancer with ADT + EBR.
排除标准
- •Everyone else
研究组 & 干预措施
N-111
Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast.
干预措施: N-111 (Dietary Supplement)
Placebo
A placebo that is inert but appears to look the same as the active comparator in conjunction with ADT + EBR, given once per day with breakfast.
干预措施: Placebo (Other)
Control
The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo.
结局指标
主要结局
Self-reporting
时间窗: Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).
Self-reporting symptom severity and number of symptoms. The scoring is from 1 (no issue) to 10 (severe), across 14 questions.
次要结局
未报告次要终点