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Lindera Obtusiloba for Non-small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Lindera obtusiloba extract

About this trial

This is an interventional supportive care trial for Non Small Cell Lung Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Korean Medicine Hospital, Pusan National UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Wait-list

Arm Description

Outcomes

Primary Outcome Measures

EORTC QLQ-C30

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

EORTC QLQ-LC13

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

Secondary Outcome Measures

NK cell percentage in peripheral blood

CD4+/CD8+ T cell in peripheral blood

total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood

Full Information

NCT ID

NCT04348149

First Posted

April 10, 2020

Last Updated

April 13, 2020

Sponsor

Jun-Yong Choi

Collaborators

Korea Institute of Oriental Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04348149

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 28, 2018 (Actual)

Primary Completion Date

December 27, 2020 (Anticipated)

Study Completion Date

December 27, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jun-Yong Choi

Collaborators

Korea Institute of Oriental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Title

Wait-list

Arm Type

No Intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Lindera obtusiloba extract

Intervention Description

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.

Primary Outcome Measure Information:

Title

EORTC QLQ-C30

Description

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)

Time Frame

Change from baseline to 6-week and 8-week

Title

EORTC QLQ-LC13

Description

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

Time Frame

Change from baseline to 6-week and 8-week

Secondary Outcome Measure Information:

Title

NK cell percentage in peripheral blood

Time Frame

Change from baseline to 8-week

Title

CD4+/CD8+ T cell in peripheral blood

Time Frame

Change from baseline to 8-week

Title

total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood

Time Frame

Change from baseline to 8-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun-Yong Choi, KMD/PHD

Phone

+82-55-360-5953

orientdoct@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun-Yong Choi, KMD/PHD

Organizational Affiliation

Korean Medicine Hospital of Pusan National University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korean Medicine Hospital, Pusan National University

City

Yangsan

State/Province

Gyeongsangnam-do

ZIP/Postal Code

50612

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun-Yong Choi

kmd@pusan.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lindera Obtusiloba for Non-small Cell Lung Cancer

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