Efficacy and safety of Yifei Sanjie Recipe in the treatment of chemotherapy-related cancer-related fatigue in patients with non-small cell lung cancer: a N-of -1 multicenter randomized controlled trial

Phase 1

Recruiting

• Conditions: cancer-related fatigue

• Registration Number: ITMCTR2100004951
• 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with non-small cell lung cancer diagnosed by pathology or cytology;
2. Meet the diagnostic criteria for cancer-related fatigue;
3. The estimated survival time is more than 3 months, PS<=2, aged 18 to 80 years;
4. Patients who are not suitable for targeted drug therapy;
5. According to the guidelines, patients need to receive platinum-containing dual-drug-based chemotherapy, including AP (pemetrexed + cisplatin/carboplatin), TP (paclitaxel + cisplatin/carboplatin), DP (docetaxel) + Cisplatin/carboplatin), GP (gemcitabine + cisplatin/carboplatin); can be combined with anti-vascular drugs and immune checkpoint inhibitors;
6. Those who voluntarily accept the treatment of this program, can adhere to the follow-up visit as prescribed by the doctor and have good compliance.

Exclusion Criteria

1. Any situation that may hinder the subject from completing the clinical trial process, including but not limited to serious, difficult to control organic disease or infection, unstable angina, congestive heart failure, etc.; hypothyroidism has not been controlled;
2. Severe liver and kidney dysfunction (serum creatinine >= 1.5 ULN; ALT or AST >= 5 ULN; bilirubin >= 1.5 ULN);
3. Patients with neurological or mental disorders who are symptomatic and difficult to control, and others who cannot complete the questionnaire independently or assist by others.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Gut Microbiota;Brief fatigue inventory;

Secondary Outcome Measures

Name	Time	Method
Quality of life;Clinical symptom score;Neuroendocrine function;Immune Function;Mental Sleepy score and Mental Fatigue score;