TCM in the Treatment of Lung Adenocarcinoma

Henan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Lung Adenocarcinoma

Treatments: Drug: PC chemotherapy and symptomatic treatment; Drug: Jing-yan-kang Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT04482829

TCM for lung adenocarcinoma

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A confirmed diagnosis of LADC.
• Age ranges from17years to75years.
• A KPS score ≥40.
• Without radiotherapy, immunotherapy and targeted therapy.
• Without participanting in any other trial.
• With signed informed consent.

Exclusion criteria

• Pregnant, nursing or may become pregnant women.
• The patient has a history of allergy to any of the components of the intervention drug;
• Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular diseases.
• Unconscious or unable to communicate normally.
• Patients with poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Experimental Group

Experimental group

Description:

On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily.

Treatment:

Drug: Jing-yan-kang Granule

Drug: PC chemotherapy and symptomatic treatment

Control Group

Other group

Description:

All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.

Treatment:

Drug: PC chemotherapy and symptomatic treatment