Non Small Cell Lung Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLindera 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.
Sponsors
Jun-Yong Choi
Korea Institute of Oriental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 | 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. |
| EORTC QLQ-LC13 | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJun-Yong Choi, KMD/PHD
Korean Medicine Hospital of Pusan National University
Outcome results
None listed