Status:
UNKNOWN
Lindera Obtusiloba for Non-small Cell Lung Cancer
Lead Sponsor:
Jun-Yong Choi
Collaborating Sponsors:
Korea Institute of Oriental Medicine
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 27 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04348149
Start Date
December 28 2018
End Date
December 27 2020
Last Update
April 16 2020
Active Locations (1)
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1
Korean Medicine Hospital, Pusan National University
Yangsan, Gyeongsangnam-do, South Korea, 50612