Lindera Obtusiloba for Non-small Cell Lung Cancer
Palavras-chave
Resumo
datas
| Última verificação: | 03/31/2020 |
| Enviado pela primeira vez: | 04/09/2020 |
| Inscrição estimada enviada: | 04/12/2020 |
| Postado pela primeira vez: | 04/15/2020 |
| Última atualização enviada: | 04/12/2020 |
| Última atualização postada: | 04/15/2020 |
| Data real de início do estudo: | 12/27/2018 |
| Data Estimada de Conclusão Primária: | 12/26/2020 |
| Data Estimada de Conclusão do Estudo: | 12/26/2020 |
Condição ou doença
Intervenção / tratamento
Dietary Supplement: Intervention group
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Intervention group | Dietary Supplement: Intervention group 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. |
| No Intervention: Wait-list |
Critério de eleição
| Idades qualificadas para estudar | 20 Years Para 20 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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 |
Resultado
Medidas de Resultado Primário
1. EORTC QLQ-C30 [Change from baseline to 6-week and 8-week]
2. EORTC QLQ-LC13 [Change from baseline to 6-week and 8-week]
Medidas de Resultado Secundário
1. NK cell percentage in peripheral blood [Change from baseline to 8-week]
2. CD4+/CD8+ T cell in peripheral blood [Change from baseline to 8-week]
3. total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood [Change from baseline to 8-week]
