Zhengyuan Capsule in the treatment of chemotherapy-related cancer-related fatigue in patients with unresectable stage IIIB-IV non-small cell lung cancer--a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial

The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Pathologically or cytologically diagnosed patients with unresectable stage IIIb-IV non-small cell lung cancer
•2. The estimated survival time is more than 3 months, ECOG PS<=2, aged 18-85 years;
•3. Patients receive platinum-based chemotherapy regimens (such as taxanes combined with cisplatin/carboplatin regimen or pemetrexed combined with cisplatin/carboplatin regimen; can be combined with anti-tumor vascular drugs or immune checkpoint inhibitors);
•4. The patient is willing to accept the treatment of this protocal, can adhere to the treatment according to the doctor's advice and has good compliance;
•5. Meet the diagnostic criteria for cancer-related fatigue, with a BFI >=4.

•1. Any situation that may hinder the subject from completing the clinical trial process, including but not limited to serious, uncontrollable organic disease or infection, unstable angina, congestive heart failure, etc.;
•2. Patients with severe liver and kidney dysfunction (serum creatinine >= 1.5 times ULN; ALT or AST >= 3 times ULN; bilirubin >= 1.5 times ULN); patients with symptomatic and difficult-to-control neurological, mental or mental disorders, Those whose thyroid function has not improved;
•3. Those who have cognitive impairment and speech expression defects, and are unable to complete the questionnaire independently or with the assistance of others;
•4. Patients with concurrent radiotherapy and chemotherapy;
•5. Women who are pregnant or breastfeeding or planning to become pregnant;
•6. Those with allergies or those who are known to be allergic to the ingredients contained in the test drug;
•7. Those who are participating in a clinical trial within three months before the trial;
•8. Patients with infectious diseases, such as active hepatitis B, AIDS, syphilis, etc.;
•9. Patients with other malignant tumors;
•10. Comply with the syndrome differentiation standard of yin deficiency and fire vigor in traditional Chinese medicine;
•11. In addition to the above, patients judged by the investigator to be unsuitable to participate in this clinical study.

发起方

The First Affiliated Hospital of Guangzhou University of Chinese Medicine