Lung Adenocarcinoma Clinical Trial
Official title:
Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma
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.
Status | Not yet recruiting |
Enrollment | 144 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Henan University of Traditional Chinese Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline. | |
Primary | 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. | Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline. | |
Secondary | 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. | Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline. | |
Secondary | 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. | Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline. | |
Secondary | Change of tumor volume | Change of tumor volume will be assessed by the length of longest diameter. The longger diameter will indicate worse disease. | Change at 12 weeks after treatment compared to baseline. | |
Secondary | Adverse events will be evaluated and recorded at any time. | Safety | at baseline, up to 6 weeks and 12 weeks after treatment. |
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