NCT04482829

TCM in the Treatment of Lung Adenocarcinoma

Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study.

Detailed description

Lung adenocarcinoma (LUAD) is a type of non-small cell lung cancer (NSCLC) with a rapid disease progression and poor treatment effect. The LUAD patients have a short median survival time with 8-11 months. Up to now, chemotherapy is still the first-line treatment for LUAD. PC protocol (pemetrexed + cisplatin) is most commonly used, which is also recommended by NCCN guidelines. However, critical side effects have limited the application and efficacy. Patients will undergo poor quality of life, and the disease will progress rapidly. We still face the stern situation for the treatment of LUAD. It is urgent to develop new treatment and management strategies. Our previous study showed that jing-yuan-kang granule has certain curative effect on LUAD. This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a 2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 1:1. On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group. The primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores, clinical symptoms, and change of tumor volume. Safety and adverse events will also be assessed.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Jing-yan-kang Granule	Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
DRUG	PC chemotherapy and symptomatic treatment	Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle. Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed. If necessary, symptomatic treatment will also be used.

Timeline

• Start date: 2020-09-15
• Primary completion: 2020-12-30
• Completion: 2022-06-30
• First posted: 2020-07-23
• Last updated: 2020-07-23