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

Phase 4

Completed

• Conditions: Cancer-related fatigue

• Registration Number: ITMCTR2000004062
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified