Lindera Obtusiloba for Non-small Cell Lung Cancer

NCT ID: NCT04348149

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2020-12-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Lindera obtusiloba extract

Intervention Type: 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.

Wait-list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: collaborator

Jun-Yong Choi

OTHER

Sponsor Role: lead

Responsible Party

Jun-Yong Choi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jun-Yong Choi, KMD/PHD

Role: PRINCIPAL_INVESTIGATOR

Korean Medicine Hospital of Pusan National University

Locations

Korean Medicine Hospital, Pusan National University

Yangsan, Gyeongsangnam-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jun-Yong Choi, KMD/PHD

Role: CONTACT

orientdoct@gmail.com

+82-55-360-5953

Facility Contacts

Jun-Yong Choi

Role: primary

kmd@pusan.ac.kr

Other Identifiers

PNUKHIRB-2018012

Identifier Type: -

Identifier Source: org_study_id