Clinical trial · Interventional
Lindera Obtusiloba for Non-small Cell Lung Cancer
Adjunctive Administration of Lindera Obtusiloba on Non-small Cell Lung Cancer Patients Who Receive PD-1 Inhibitors: a Randomized Exploratory Pilot Study
NCT04348149CI-TRIAL-00121738completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lindera obtusiloba extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Dietary Supplement: Lindera obtusiloba extract
- type
- NO_INTERVENTION
- label
- Wait-list
Primary outcomes (2)
- measure
- EORTC QLQ-C30
- timeFrame
- Change from baseline to 6-week and 8-week
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.