Lindera Obtusiloba for Non-small Cell Lung Cancer (NCT04348149) | Clinical Trial Compass
CompletedNot Applicable
Lindera Obtusiloba for Non-small Cell Lung Cancer
South Korea20 participantsStarted 2018-12-28
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EORTC QLQ-C30
Timeframe: Change from baseline to 6-week and 8-week
2
EORTC QLQ-LC13
Timeframe: Change from baseline to 6-week and 8-week