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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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.
Korean Medicine Hospital, Pusan National University
Yangsan, Gyeongsangnam-do, South Korea
EORTC QLQ-C30
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.
Time frame: Change from baseline to 6-week and 8-week
EORTC QLQ-LC13
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.
Time frame: Change from baseline to 6-week and 8-week
NK cell percentage in peripheral blood
Time frame: Change from baseline to 8-week
CD4+/CD8+ T cell in peripheral blood
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Time frame: Change from baseline to 8-week
total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood
Time frame: Change from baseline to 8-week