Shiwei Yiyuan granules for treatment of cancer-related fatigue after chemotherapy in advanced cancer: a randomized double-blind controlled study

Xiyuan Hospital CACMS0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1. Patient with primary lung cancer, colorectal cancer or breast cancerwhich was proved by pathologically. Lesions can be measured and efficacy can be evaluated.( Based on efficacy evaluation criteria of treatment in solid tumor Version 1.1).
•2. Patients have received chemotherapy within 7 days.
•3. Patients who are diagnosed with cancer-related fatigue. Fatigue Score >= 4.(The degree of fatigue was scored using a 0-10 numerical rating scale, 0 = no fatigue, 10 = most severe fatigue)
•4. TCM pattern type is spleen-kidney yang deficiency or qi and blood deficiency.
•5. The score of KPS >= 70.
•6. Aged 18 to 75 years.
•7. Expected survival time >= 3 months.
•8. Patients who sign the informed consent and join the study voluntarily.

•1. Patients who have been allergic to the drug composition of Shiwei Yiyuan Granules.
•2. Abnormal liver and kidney function(ALT, AST, GGT >=1.5ULN, BUNCr>=1.5ULN).
•3. Abnormal bone marrow function (WBC count <= 2.0x10^9/L, Neutrophil count <= 1.5 x 10^9/L, Platelet count <= 100 x 10^9/L, Hemoglobin count <= 90g/L).
•4. Patients who have non-neoplastic diseases and dysfunctions in heart, lung, digestive system and other major organs (such as myocardial infarction, uncontrolled angina, obvious ventricular arrhythmia, severe heart failure, severe respiratory depression and hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, severe viral infections and toxic shocks, immune-related diseases and diseases of the blood system).
•5. Patients who cannot understand and correctly complete the rating scale.
•6. The score of Self-rating anxiety scale (SAS) and Depression self-rating scale (SDS) are more than 50 points respectively.
•7. Patients who participate in other clinical trials in the past 1 month.

发起方

Xiyuan Hospital CACMS