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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

Summary

This study tests whether Ganoderma lucidum spore powder, a traditional Chinese medicine supplement, can help reduce fatigue in lung cancer patients taking the drug Osimertinib. Fatigue is a major side effect that affects most patients on this medication. The 140-patient trial compares patients receiving the supplement plus Osimertinib with those receiving a placebo plus Osimertinib, measuring fatigue levels and quality of life over 8 weeks.

Background

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor with promising efficacy for advanced non-squamous NSCLC patients with T790M mutation, but fatigue is a major adverse effect affecting more than two-thirds of patients. Ganoderma lucidum spore powder (GLSP) has been traditionally used to combat fatigue and possesses anti-inflammatory, antioxidant, and immunomodulatory properties.

Objective

This study aims to investigate whether de-walled GLSP is effective and safe in improving Osimertinib-induced fatigue and synergizing with Osimertinib in non-squamous NSCLC patients with EGFR mutations. The study will also explore immune indicators and gut microbiota relationships underlying the therapeutic mechanism.

Results

This is a protocol paper describing a trial in progress; results are not yet available. The study began recruitment in August 2023 with completion scheduled for February 2026.

Conclusion

This will be the first multicenter randomized controlled trial investigating GLSP on Osimertinib-induced fatigue and its underlying immune mechanisms. Results are expected to provide evidence for GLSP use in managing fatigue in advanced NSCLC patients receiving targeted therapy.
  • Published in:BMC Complementary Medicine and Therapies,
  • Study Type:Clinical Trial - Protocol,
  • Source: PMID: 38500118, DOI: 10.1186/s12906-024-04416-2
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