Lindera Obtusiloba for Non-small Cell Lung Cancer

Jun-Yong Choi

Status

Unknown

Conditions

Non Small Cell Lung Cancer

Treatments

Dietary Supplement: Lindera obtusiloba extract

Study type

Interventional

Funder types

Other

Identifiers

NCT04348149

PNUKHIRB-2018012

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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