Article ; Online: Synergy of de-walled Ganoderma Lucidum spore powder (GLSP) on targeted therapy in advanced non-squamous non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutant: protocol for a randomized, double-blind, placebo-controlled study.
BMC complementary medicine and therapies
2024 Volume 24, Issue 1, Page(s) 125
Abstract: Background: Osimertinib is regarded as a promising third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for advanced non-squamous non-small cell lung cancer (NSCLC) patients who developed T790M. However the adverse ... ...
Abstract | Background: Osimertinib is regarded as a promising third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for advanced non-squamous non-small cell lung cancer (NSCLC) patients who developed T790M. However the adverse effects, primarily fatigue, remain an overwhelming deficiency of Osimertinib, hindering it from achieving adequate clinical efficacy for such NSCLC. Ganoderma lucidum has been used for thousands of years in China to combat fatigue, while Ganoderma Lucidum spores powder (GLSP) is the main active ingredient. The aim of this study is to investigate whether GLSP is sufficiently effective and safe in improving fatigue and synergizing with Osimertinib in non-squamous NSCLC patients with EGFR mutant. Method/design: A total of 140 participants will be randomly assigned to receive either de-walled GSLP or placebo for a duration of 56 days. The primary outcome measure is the fatigue score associated with EGFR-TKI adverse reactions at week 8, evaluated by the Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Patients (QLQ-C30). Secondary outcomes include evaluation of treatment effectiveness, assessment of quality of life (QoL), and exploration of immune indicators and gut microbiota relationships. Following enrollment, visits are scheduled biweekly until week 12. Trial registration: China Clinical Trial Registry ChiCTR2300072786. Registrated on June 25, 2023. |
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MeSH term(s) | Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Reishi ; Quality of Life ; Powders/therapeutic use ; ErbB Receptors/genetics ; Protein Kinase Inhibitors/adverse effects ; Mutation ; Spores, Fungal ; Randomized Controlled Trials as Topic ; Acrylamides ; Aniline Compounds ; Indoles ; Pyrimidines |
Chemical Substances | osimertinib (3C06JJ0Z2O) ; Powders ; ErbB Receptors (EC 2.7.10.1) ; Protein Kinase Inhibitors ; EGFR protein, human (EC 2.7.10.1) ; Acrylamides ; Aniline Compounds ; Indoles ; Pyrimidines |
Language | English |
Publishing date | 2024-03-18 |
Publishing country | England |
Document type | Clinical Trial Protocol ; Journal Article |
ISSN | 2662-7671 |
ISSN (online) | 2662-7671 |
DOI | 10.1186/s12906-024-04416-2 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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