The efficacy of Qidongbufei Decoction in treating NSCLC postoperative symptoms: a randomized, double-blind, placebo-controlled pilot study

Phase 1

Recruiting

• Conditions: non-small cell lung cancer

• Registration Number: ITMCTR2000003983
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences.

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. Postoperative patients with NSCLC in stage I, confirmed by pathology or cytology;
2. Enrolled within 2 weeks after surgery;
3. The surgical mode is single hole thoracoscopic lobectomy
4. Aged 18-75 years;
5. ECOG 0-2 scores;
6. The expected survival time equal or greater than 6 months;
7. NEUT >1.5 x 10^9/L, PLT > 100 x 10^9/L, Hb > 9.0g/dl, TBIL normal or > 1.5 ULN; AST (SGOT)ALT (SGPT) < 2.5 ULN, CRE < 1.5 ULN.

Exclusion Criteria

1. Patients who received neoadjuvant chemotherapy before surgery;
2. Patients who plan to receive other treatments such as radiotherapy, chemotherapy, targeted therapy, etc.within 1 month after surgery;
3. Severe complications like pulmonary embolism, respiratory failure and myocardial infarction occurred during the perioperative period;
4. In other clinical trials;
5. Pregnant or lactating patients;
6. Having a history of mental illness that is difficult to control;
7. Allergic to study drugs;
8. Cannot understand and refuse to sign informed consent;
9. Cannot cooperate with the scale data collection.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
symptom threshold events reduction rate;

Secondary Outcome Measures

Name	Time	Method
quality of life;lung function; mean symptom interference;