CLINICAL TRIAL article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1615505
Ginkgo ketone ester tablets for the treatment of cognitive impairment associated with chemotherapy for breast cancer -a prospective cohort study
Provisionally accepted
- 1Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
- 2Department of Breast Surgery, Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
- 3Shanghai XingLing Technology Pharmaceutical Co., Shanghai, China
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Background Chemotherapy-related cognitive impairment (CRCI) affects up to 75% of breast cancer patients during treatment, with 35% experiencing persistent post-treatment deficits. Current interventions show limited efficacy, creating urgent need for targeted therapies. Ginkgo Ketone Ester (GBE), containing neuroprotective flavonoids and terpene lactones, represents a potential therapeutic strategy.This 24-week prospective cohort study enrolled 96 breast cancer patients (stage I-III) receiving anthracycline-based chemotherapy. Participants were allocated to GBE intervention (n=48) or standard care (n=48) groups. The GBE cohort received tablets containing 14.08-21.12mg total flavonoids, ≥9.6mg flavonol glycosides, and ≥2.4mg terpene lactones (0.25g, three times daily) for 12 weeks. Cognitive function was assessed using Memory and Executive Screening (MES), Auditory Verbal Learning Test-Huashan Version (AVLT-H), and Shape Trail Test A/B at baseline, week 12, and week 24. Serum biomarkers (glutathione [GSH], reactive oxygen species [ROS], tumor necrosis factor-alpha [TNF-α])and quality of life measures were evaluated correspondingly.Results GBE administration significantly improved cognitive performance compared to controls (P<0.05). The intervention group demonstrated 23% higher MES scores (72.29±9.09 vs 64.42±8.63 at week 24), 31% better AVLT-H performance, and maintained stable completion times. Biochemical analysis revealed substantial GSH elevation (56% increase) and ROS reduction (41% decrease) at week 24, while TNF-α remained unchanged. CRCI incidence was significantly lower in the GBE group (66.67% vs 89.58%, P<0.007). Treatment compliance reached 89% with no serious adverse events reported.Conclusion GBE demonstrates significant promise as a neuroprotective intervention for CRCI management, with substantial improvements in cognitive function and oxidative stress biomarkers. The favorable efficacy profile, excellent safety record, and high compliance support GBE's potential as adjunctive CRCI therapy. While neuroinflammatory effects were limited, robust antioxidant restoration and cognitive enhancement warrant further investigation through large-scale randomized controlled trials to validate long-term efficacy and optimize clinical protocols.
Keywords: breast cancer, chemotherapy-related cognitive impairment, Ginkgo ketone ester, Neuroprotection, oxidative stress Clinical Trial Registration: This study was registered in the China Clinical Research Registry (ChiCTR) under the registration number ChiCTR2200065694 on November 11, 2022
Received: 28 Apr 2025; Accepted: 03 Jul 2025.
Copyright: © 2025 Chen, Chen, Jiang, Wang, Wu, Qin and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Sheng Liu, Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
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