Clinical trial NCT04348149: Lindera Obtusiloba for Non-small Cell Lung Cancer
Official title: Adjunctive Administration of Lindera Obtusiloba on Non-small Cell Lung Cancer Patients Who Receive PD-1 Inhibitors: a Randomized Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2020-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 are receiving PD-1 or PD-L1 inhibitors.


Eligibility criteria: 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

Primary outcomes:
measure: EORTC QLQ-C30
timeFrame: Change from baseline to 6-week and 8-week
measure: EORTC QLQ-LC13
timeFrame: Change from baseline to 6-week and 8-week
Secondary outcomes:
measure: NK cell percentage in peripheral blood
timeFrame: Change from baseline to 8-week
measure: CD4+/CD8+ T cell in peripheral blood
timeFrame: Change from baseline to 8-week
measure: total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood
timeFrame: Change from baseline to 8-week
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Korean Medicine Hospital, Pusan National University
state: Gyeongsangnam-do
Study officials:
affiliation: Korean Medicine Hospital of Pusan National University
name: Jun-Yong Choi, KMD/PHD
role: PRINCIPAL_INVESTIGATOR
References: