Efficacy and safety of Ginkgo biloba for cognitive function and fatigue in breast cancer patients undergoing adjuvant chemotherapy: A randomised, controlled trial (#331)
Background: Women treated for breast cancer (BC) commonly ingest herbal medicines. Ginkgo biloba (GB) is widely used in the general and cancer communities for memory problems. Many women report difficulties with memory after BC treatment. Little is known about the herb-drug interactions or potential effectiveness of GB in managing cognitive changes in this population.
Aims: 1) to evaluate the efficacy of ginkgo biloba in reducing cognitive impairment in women receiving adjuvant chemotherapy for early breast cancer; ii) to evaluate the safety of ginkgo biloba in this population.
Methods: This is an RCT of 120mg twice daily of GB (EGb 761) or placebo for 12 months in women commencing adjuvant chemotherapy treatment for BC. Participants are recruited from Sydney hospitals. Their neuropsychological performance, quality of life, anxiety and depression, stress, toxicity and cancer treatment outcomes are assessed. Substudies investigating pharmacokinetic impact of GB on hormone therapy or chemotherapy are included. Substudy participants received GB for 3 weeks: trough concentrations of drugs were measured before and after GB.
Results: Project funding from ASCO, Cancer Australia and partners has allowed the study to commence. Progress has been slowed by a number of challenges including: need for preliminary data regarding GB-drug interactions and toxicity, change in NSW Health pharmacy policy, drug expiry, recruitment timing related to women’s clinical decision-making, time commitment for neuropsychological assessments. To date we have completed the substudy of GB-hormonal therapy, demonstrating trough concentrations and toxicity before and after treatment with GB was not significantly different. The main study is open at 2 sites with further sites pending.
Conclusions: Setting up an RCT of a complementary medicine is as complex as trials of standard drugs and should not be under-estimated. This study will determine whether GB improves cognitive function in women undergoing chemotherapy and confirm evidence of pharmacokinetic and safety data.