NCT00647075Unknown4 期
A Randomized, Parallel, Double-blind, Placebo-controlled, Pilot Clinical Study on the Effects of Yunzhi as Dietary Supplement in 60 Adult Patients Undergoing Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with diagnosis of breast cancer
- •Undergoing adjuvant/neoadjuvant chemotherapy with either FEC, FAC, TAC, or EC + docetaxel combinations.
- •≥ 18 years of age
- •Performance status: 0-2
- •Ability to provide written informed consent
排除标准
- •Any prior history of yunzhi use
- •Use of other herbal remedies during the study duration
- •Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation
- •Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization)
- •Systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)
研究组 & 干预措施
1
Experimental
Yunzhi extract 3.5 g/day
干预措施: Yunzhi extract (Dietary Supplement)
2
Placebo Comparator
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)
时间窗: 6 months
次要结局
- Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs(6 months)
研究者
研究点 (2)
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