Adjunctive Administration of Lindera Obtusiloba on Non-small Cell Lung Cancer Patients Who Receive PD-1 Inhibitors: a Randomized Exploratory Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- EORTC QLQ-C30
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Wait-list
Intervention group
Intervention: Lindera obtusiloba extract (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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
- 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)
- NK cell percentage in peripheral blood(Change from baseline to 8-week)
Investigators
Jun-Yong Choi
Professor
Korean Medicine Hospital of Pusan National University