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| Name | Class |
|---|---|
| Korea Institute of Oriental Medicine | OTHER_GOV |
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This randomized, open labelled, non-treatment-controlled study evaluates the safety and efficacy of Lindera obtusiloba, a dietary food, on quality of life of non-small cell lung cancer patients who are receiving PD-1 or PD-L1 inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Wait-list | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lindera obtusiloba extract | Dietary Supplement | One package of dietary supplement contains one gram of 70% ethanol extracted powder of Lindera obtusiloba and one gram of glucose powder. Participants intake one package per day for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) | Change from baseline to 6-week and 8-week |
| EORTC QLQ-LC13 | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) | Change from baseline to 6-week and 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| NK cell percentage in peripheral blood | Change from baseline to 8-week | |
| CD4+/CD8+ T cell in peripheral blood | Change from baseline to 8-week | |
| total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-Yong Choi, KMD/PHD | Contact | +82-55-360-5953 | orientdoct@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun-Yong Choi, KMD/PHD | Korean Medicine Hospital of Pusan National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korean Medicine Hospital, Pusan National University | Recruiting | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Change from baseline to 8-week |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |