Clinical trial NCT04482829: TCM in the Treatment of Lung Adenocarcinoma
Official title: Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Adenocarcinoma
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale
timeFrame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
measure: Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)
timeFrame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Secondary outcomes:
measure: Karnofsky(KPS) scores
timeFrame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
measure: TCM syndrome index
timeFrame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
measure: Change of tumor volume
timeFrame: Change at 12 weeks after treatment compared to baseline.
measure: Adverse events will be evaluated and recorded at any time.
timeFrame: at baseline, up to 6 weeks and 12 weeks after treatment.
Other outcomes:
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