Lindera Obtusiloba for Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Adjunctive Administration of Lindera Obtusiloba on Non-small Cell Lung Cancer Patients Who Receive PD-1 Inhibitors: a Randomized Exploratory Pilot Study

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Dietary Supplement: Lindera obtusiloba extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged ≥ 20 years Patients who have understood and signed the informed consent. Subjects who have been confirmed histologically and radiologically for non small cell lung cancer and are scheduled to receive treatment with immune checkpoint inhibitors Subjects whose urine HCG are negative and who have agreed with the appropriate method of contraception in case of women of childbearing potential Subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires Subjects who can follow up during the clinical trial Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 Hemoglobin ≥ 9g/dL Exclusion Criteria: Subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception Subjects who have symptomatic and uncontrolled brain or central nervous system metastasis Subjects who complain of uncontrolled pain despite using analgesics Diastolic Blood Pressure>100mmHg or Systolic Blood Pressure>160mmHg Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels higher than 2.5 times the upper limit for normal Creatinine level higher than 1.5 times the upper limit for normal Subjects who have participated in other clinical trials within 1 months Subjects with a history of serious drug allergies or who have hypersensitivity to the Investigational Product (the main ingredient and its components) Subjects with autoimmune diseases Subjects who have alcoholism or drug dependence Subjects who have cognitive impairment or psychiatric problems Subjects who have undergone surgery within 2 weeks Subjects who took other herbal medicine or other medicines within 4 weeks Subjects who have a medical condition that is likely to affect results or who are determined to be inappropriate to participate in this clinical trial at the investigator

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Dietary Supplement: Lindera obtusiloba extract<br>* 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.<br>|
| No Intervention: Wait-list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Change from baseline to 8-week |