Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy- a Double Blinded, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.
研究概览
简要总结
The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could minimize the gastrointestinal symptom of cancer patients with chemotherapy.
详细描述
In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and hemoglobin increase after 2 months; liver glutamic pyruvic transaminase(GPT) index mitigation, P <0.05 difference statistically; In addition, liver glutamate oxaloacetate transaminase(GOT) and biochemical index of renal function had no abnormal data statistically. However, cancer patients with gastrointestinal disorders after chemotherapy is known to be a common side effect, we seek to investigate if Antrodia Cinnamomea improves the function of gastrointestinal system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed Cancer.
- •Age ≦ 80 years old and ≧ 18 years old.
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0-
- •Adequate organ function, including followings Hepatic： Total bilirubin level ≦1.5 x UNL, GOT and GPT ≦ 2.5 x UNL if no liver metastasis; GOT and GPT ≦ 5 x UNL if liver metastasis. Renal： Creatinine level< 1.5 milligram per deciliter or Estimated creatinine clearance(CCr) ≧ 60 milliliter per minute (CCr is estimated by Cockcroft-Gault formula, as appendix II)
- •Estimated life expectancy of at least 12 weeks.
- •Written(signed) Informed Consent
- •Ever treated and poor tolerance with platinum-based or anthracycline- based regimen, likely nausea and vomiting.
排除标准
- •Prior participation in any investigational drug study within 28 days
- •Active uncontrolled infections or human immunodeficiency virus(HIV) infection
- •Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction( 6 months before randomization), chronic obstructive pulmonary disease with frequent exacerbation, chronic renal diseases (estimated CCr 60 milliliter per minute), uncontrolled diabetes, uncontrolled hypertension, recent cerebrovascular disease episode( 6 months before randomization )
- •With clinically significant Gastrointestinal disorder (e.g. bleeding, inflammation, obstruction or diarrhea)
- •Psychiatric disorders that would compromise the patient's compliance or decision.
- •Pregnancy or breast feeding.
- •Known hypersensitivity to the component of investigational drugs.
- •Known or suspected Gilbert's syndrome
- •Poor compliance
结局指标
主要结局
Gastrointestinal symptoms in case group reduces 10% than control group during chemotherapy.
时间窗: 1 month
Post-chemotherapy nausea, vomiting and epigastragia, etc. including gastrointestinal symptom/sign without mention above.
次要结局
- Life quality estimates of 10% improvement than control group.(3 months)