Lindera Obtusiloba for Non-small Cell Lung Cancer

NCT04348149 | Unknown

• 1 other identifier: PNUKHIRB-2018012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Dietary Supplement: Lindera obtusiloba extract

Wait-list

NO INTERVENTION

Interventions

Lindera obtusiloba extract DIETARY_SUPPLEMENT

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.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jun-Yong Choi: lead
• Korea Institute of Oriental Medicine: collaborator

Study Sites (1)

Korean Medicine Hospital, Pusan National University

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jun-Yong Choi, KMD/PHD

  Korean Medicine Hospital of Pusan National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Yong Choi, KMD/PHD

CONTACT

+82-55-360-5953; orientdoct@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 16, 2020
• Study Start: December 28, 2018
• Primary Completion: December 27, 2020
• Study Completion: December 27, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)