Top

BMC Complementary Medicine and Therapies

Published in:

Open Access 01-12-2024 | NSCLC | Study Protocol

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

Authors: Tong-Tong Wu, Yu-Yi Chen, Zi-Chun Yuan, Guo-Wang Yang, Gan-Lin Zhang

Published in: BMC Complementary Medicine and Therapies | Issue 1/2024

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.

Sung H, Ferlay J, Siegel RL, et al. Global Cancer statistics 2020: GLOBOCAN estimates of incidence and Mortality Worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. https://doi.org/10.3322/caac.21660.CrossRefPubMed

The Lancet. Lung cancer: some progress, but still a lot more to do. Lancet. 2019;394(10212):1880. https://doi.org/10.1016/S0140-6736(19)32795-3.CrossRefPubMed

Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-Mutated Advanced Non-small-cell Lung Cancer. N Engl J Med. 2018;378(2):113–25. https://doi.org/10.1056/NEJMoa1713137.CrossRefPubMed

Wu YL, Tsuboi M, He J, et al. Osimertinib in Resected EGFR-Mutated non-small-cell Lung Cancer. N Engl J Med. 2020;383(18):1711–23. https://doi.org/10.1056/NEJMoa2027071.CrossRefPubMed

Luo Qin, Wang Yuzhu, Xiao Meng et al. The relationship between adverse reactions and disease remission of lung cancer targeted drug therapy. Drug Eval. 2012;19(18):1131–33.

Yin Y, Shu Y, Zhu J, et al. A real-world pharmacovigilance study of FDA adverse event reporting System (FAERS) events for osimertinib. Sci Rep. 2022;12(1):19555. https://doi.org/10.1038/s41598-022-23834-1.CrossRefPubMedPubMedCentral

Zwierenga F, van Veggel B, Hendriks LEL, et al. High dose osimertinib in patients with advanced stage EGFR exon 20 mutation-positive NSCLC: results from the phase 2 multicenter POSITION20 trial. Lung Cancer. 2022;170:133–40. https://doi.org/10.1016/j.lungcan.2022.06.012.CrossRefPubMed

Sebastian M, Rydén A, Walding A, et al. Patient-reported symptoms possibly related to treatment with osimertinib or chemotherapy for advanced non-small cell lung cancer. Lung Cancer. 2018;122:100–6. https://doi.org/10.1016/j.lungcan.2018.05.003.CrossRefPubMed

Quinten C, Maringwa J, Gotay CC, et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011;103(24):1851–8. https://doi.org/10.1093/jnci/djr485. Epub 2011 Dec 7.CrossRefPubMedPubMedCentral

10.

Groenvold M, Petersen MA, Idler E, et al. Psychological distress and fatigue predicted recurrence and survival in primary breast cancer patients. Breast Cancer Res Treat. 2007;105(2):209–19. https://doi.org/10.1007/s10549-006-9447-x. Epub 2007 Jan 3.CrossRefPubMed

11.

Bohlius J, Bohlke K, Castelli R, et al. Management of Cancer-Associated Anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice Guideline Update. J Clin Oncol. 2019;37(15):1336–51. https://doi.org/10.1200/JCO.18.02142.CrossRefPubMed

12.

Thekdi SM, Trinidad A, Roth A. Psychopharmacology in cancer. Curr Psychiatry Rep. 2015;17(1):529. https://doi.org/10.1007/s11920-014-0529-x.CrossRefPubMed

13.

Sohretoglu D, Huang S. Ganoderma Lucidum Polysaccharides as an anti-cancer Agent. Anticancer Agents Med Chem. 2018;18(5):667–74. https://doi.org/10.2174/1871520617666171113121246.CrossRefPubMedPubMedCentral

14.

Leighl NB, Karaseva N, Nakagawa K, et al. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020;125:49–57. https://doi.org/10.1016/j.ejca.2019.11.006.CrossRefPubMed

15.

Cocks K, Buchanan J. How scoring limits the usability of minimal important differences (MIDs) as responder definition (RD): an exemplary demonstration using EORTC QLQ-C30 subscales. Qual Life Res. 2022 Jul;9. https://doi.org/10.1007/s11136-022-03181-4.

16.

Villaruz LC, Socinski MA. The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement. Clin Cancer Res. 2013;19(10):2629–36. https://doi.org/10.1158/1078-0432.CCR-12-2935.CrossRefPubMedPubMedCentral

17.

Berger AM, Abernethy AP, Atkinson A, et al. NCCN Clinical Practice Guidelines Cancer-related fatigue. J Natl Compr Canc Netw. 2010;8(8):904–31. https://doi.org/10.6004/jnccn.2010.0067.CrossRefPubMed

18.

Vogelzang NJ, Breitbart W, Cella D, et al. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. Fatigue Coalition Semin Hematol. 1997;34(3 Suppl 2):4–12.PubMed

19.

Bower JE. Cancer-related fatigue–mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014;11(10):597–609. https://doi.org/10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.CrossRefPubMedPubMedCentral

20.

Yuchen Z. Zhao Yan. Study on the mechanism of tonifying qi and strengthening spleen traditional Chinese Medicine with thunder fire moxibustion in the treatment of Cancer-related fatigue. Mod Distance Educ Chin Tradit Med. 2023;21(19):201–3.

21.

Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for Symptom Monitoring during Routine Cancer Treatment. JAMA. 2017;318(2):197–8. https://doi.org/10.1001/jama.2017.7156.CrossRefPubMedPubMedCentral

Title: 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
Authors: Tong-Tong Wu
Yu-Yi Chen
Zi-Chun Yuan
Guo-Wang Yang
Gan-Lin Zhang
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: NSCLC
NSCLC
Osimertinib
Fatigue
Targeted Therapy
Published in: BMC Complementary Medicine and Therapies / Issue 1/2024
Electronic ISSN: 2662-7671
DOI: https://doi.org/10.1186/s12906-024-04416-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Method/design

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method/design

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

Protective effect of Ganoderma lucidum-fermented crop extracts against hydrogen peroxide- or β-amyloid-induced damage in human neuronal SH-SY5Y cells

In vitro anti-HIV, cytotoxicity and nutritional analysis of Trianthema portulacastrum L. (Aizoaceae)

Extrapolation errors in Liu et al.’s CAM integrative review of health care professionals in New Zealand

Cepharanthine synergistically promotes methylprednisolone pharmacodynamics against human peripheral blood mononuclear cells possibly via regulation of P-glycoprotein/glucocorticoid receptor translocation

The impact of seasonal variation on the composition of the volatile oil of Polyalthia suberosa (Roxb.) Thwaites leaves and evaluation of its acetylcholinesterase inhibitory activity

Therapeutic effect of curcumin nanoemulsion on cystic echinococcosis in BALB/c mice: a computerized tomography (CT) scan and histopathologic study evaluation