Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- T-lymphocyte cell subsets
研究概览
简要总结
This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
详细描述
GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lung cancer and breast cancer patients confirmed by surgery pathology;
- •ECOG physical stamina score of 0~3 points;
- •Expected lifetime > 3 months;
- •Need to receive radiation and chemotherapy;
- •Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
- •To follow-up, good adherence
排除标准
- •Allergic to text drug;
- •Pregnancy or lactation women;
- •Suffering from mental illness of not easy to control,
- •Have serious mental or cognitive dysfunction;
- •Can not comply with the experimental scheme or can't cooperate with the follow-up;
- •The patients who are unfavorable to the subject.
研究组 & 干预措施
GLSE compound group
GLSE compound 2g each time by mouth,twice a day for 42 days.
干预措施: GLSE compound (Drug)
Maitake mushroom extract compound group
Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.
干预措施: Maitake mushroom extract compound (Drug)
Ginseng compound group
Ginseng compound 2 tables each time by mouth,twice a day for 42 days.
干预措施: Ginseng compound (Drug)
结局指标
主要结局
T-lymphocyte cell subsets
时间窗: three mouths
T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level
次要结局
未报告次要终点
研究者
Zhiyong Wu
Associate Chief Physician
Chinese PLA General Hospital