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Completed

NCT Number: NCT04348149

Lindera Obtusiloba for Non-small Cell Lung Cancer

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korean Medicine Hospital, Pusan National University

Yangsan, Gyeongsangnam-do, 50612, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. EORTC QLQ-C30

    Time frame: Change from baseline to 6-week and 8-week

    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a 30-item patient-reported questionnaire comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality-of-life scale, and six single-item symptom measures. Each scale or item score is linearly transformed to a range from 0 to 100 (minimum: 0; maximum: 100). Higher scores on the functional scales and the global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales and single-item symptom measures indicate greater symptom severity and therefore a worse outcome. Changes from baseline will be assessed at Weeks 6 and 8.

  2. EORTC QLQ-LC13

    Time frame: Change from baseline to 6-week and 8-week

    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) is a 13-item lung cancer-specific patient-reported questionnaire used in conjunction with the EORTC QLQ-C30. It assesses lung cancer-related symptoms and treatment-related problems, including dyspnoea, coughing, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, and pain at specific sites. Scores for the dyspnoea scale and individual symptom items are linearly transformed to a range from 0 to 100 (minimum: 0; maximum: 100). Higher scores indicate greater symptom severity or treatment-related problems and therefore a worse outcome. Changes from baseline will be assessed at Weeks 6 and 8.

Secondary outcomes

  1. NK cell percentage in peripheral blood

    Time frame: Change from baseline to 8-week

  2. CD4+/CD8+ T cell in peripheral blood

    Time frame: Change from baseline to 8-week

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

    Time frame: Change from baseline to 8-week

Sponsors and collaborators

Lead sponsor

Jun-Yong Choi

Other

Collaborators

  • Korea Institute of Oriental Medicine

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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