Synergy of de-walled Ganoderma Lucidum spore powder (GLSP) on targeted therapy in advanced non-squamous non-small...

Area of Science:

• Oncology
• Pharmacology
• Traditional Chinese Medicine

Background:

• Osimertinib, a third-generation EGFR TKI, treats advanced NSCLC but causes significant fatigue.
• Fatigue limits Osimertinib's clinical efficacy in EGFR-mutant NSCLC patients.
• Ganoderma lucidum, a traditional Chinese herb, is known for its anti-fatigue properties, with its spores powder (GLSP) being the active component.

Purpose of the Study:

• To evaluate the efficacy and safety of GLSP in alleviating fatigue in non-squamous NSCLC patients receiving Osimertinib.
• To assess the synergistic effects of GLSP with Osimertinib in this patient population.
• To explore the impact of GLSP on quality of life, immune indicators, and gut microbiota.

Main Methods:

• A randomized, placebo-controlled trial involving 140 participants with non-squamous NSCLC and EGFR mutations.
• Participants will receive either de-walled GLSP or a placebo for 56 days.
• The primary outcome is the change in fatigue score at week 8, measured by the EORTC QLQ-C30.

Main Results:

• Data collection and analysis are ongoing; results are pending.
• The study aims to provide quantitative data on GLSP's impact on fatigue and quality of life.
• Exploratory analyses will investigate potential biomarkers related to immune function and gut microbiome.

Conclusions:

• The study is expected to determine if GLSP is a safe and effective complementary therapy for Osimertinib-induced fatigue in NSCLC patients.
• Findings may support the integration of GLSP into clinical practice to improve patient outcomes and treatment adherence.
• This research could offer novel insights into managing treatment-related adverse effects in precision oncology.