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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
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.
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
A score of 1-4 will be administrated for each item in EORTC QLQ-C30 . The higher scores will indicate the worse outcomes.
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)
A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Karnofsky(KPS) scores
Physical conditions will be evaluated by KPS scores with a score of 0-100. A higher score will indicate a better physical conditon.
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
TCM syndrome index
TCM symptom index will be recorded and calculated referring to the Guiding Principles of Clinical Research of New Chinese Medicine Treating Primary Bronchial Lung Cancer (2002 Edition) published by National Medical Products Administration of China. A total of scores of all the related symptoms will be calculated with a 0-4 for each symptom at baseline and after treatment. A higher value will indicate a worse symptom. The difference of TCM symptoms between baseline and posttreatment will be calculated first. Then, we will obtain the TCM syndrome index by the ratio between the above difference and the scores at baseline.
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Change of tumor volume
Change of tumor volume will be assessed by the length of longest diameter. The longger diameter will indicate worse disease.
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Time frame: Change at 12 weeks after treatment compared to baseline.
Adverse events will be evaluated and recorded at any time.
Safety
Time frame: at baseline, up to 6 weeks and 12 weeks after treatment.