Lindera Obtusiloba for Non-small Cell Lung Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Dietary supplement: Lindera obtusiloba extract

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun-Yong Choi, KMD/PHD; Phone Number: +82-55-360-5953; Email: orientdoct@gmail.com

Study Locations

• Korea, Republic of
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Recruiting
      • Korean Medicine Hospital, Pusan National University
      • Contact: Jun-Yong Choi; Email: kmd@pusan.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Dietary supplement: Lindera obtusiloba extract; 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.
No Intervention: Wait-list

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Jun-Yong Choi
• Collaborators: Korea Institute of Oriental Medicine
• Investigators: Principal Investigator: Jun-Yong Choi, KMD/PHD, Korean Medicine Hospital of Pusan National University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2018
• Primary Completion (Anticipated): December 27, 2020
• Study Completion (Anticipated): December 27, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PNUKHIRB-2018012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No