Lindera Obtusiloba for Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04348149
• Other study ID #: PNUKHIRB-2018012
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2018
• Est. completion date: December 27, 2020

Study information

• Verified date: April 2020
• Source: Korean Medicine Hospital of Pusan National University
• Contact: Jun-Yong Choi, KMD/PHD
• Phone: +82-55-360-5953
• Email: orientdoct[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 27, 2020
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Korean Medicine Hospital, Pusan National University	Yangsan	Gyeongsangnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Jun-Yong Choi	Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	NK cell percentage in peripheral blood		Change from baseline to 8-week
Secondary	CD4+/CD8+ T cell in peripheral blood		Change from baseline to 8-week
Secondary	total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood		Change from baseline to 8-week