학술논문
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.
Document Type
Academic Journal
Author
Wu TT; Department of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23, Back Road of Art Gallery, Dongcheng District, Beijing, 100010, China.; Chen YY; Department of Oncology, Shunyi Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing, China.; Yuan ZC; Department of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23, Back Road of Art Gallery, Dongcheng District, Beijing, 100010, China.; Yang GW; Department of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23, Back Road of Art Gallery, Dongcheng District, Beijing, 100010, China. guowang_yang@163.com.; Zhang GL; Department of Oncology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23, Back Road of Art Gallery, Dongcheng District, Beijing, 100010, China. kalinezhang@163.com.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 101761232 Publication Model: Electronic Cited Medium: Internet ISSN: 2662-7671 (Electronic) Linking ISSN: 26627671 NLM ISO Abbreviation: BMC Complement Med Ther Subsets: MEDLINE
Subject
Language
English
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.
(© 2024. The Author(s).)
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.
(© 2024. The Author(s).)