Barton, D.L., Burger, K., Novotny, P.J., Fitch, T. R., Kohli, S., Soori, G., . . . Loprinzi, C.L. (2013). The use of ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9. Supportive Care in Cancer, 21, 1185–1192.

Evaluate ginkgo biloba for the prevention of cognitive decline associated with adjuvant treatment for breast cancer

Patients were randomized to receive 60 mg of ginkgo biloba or a matching placebo twice a day starting before the second cycle of thermotherapy and continuing throughout treatment and 1 month beyond chemotherapy completion. Participants were stratified by type of chemotherapy, age, menopausal status, and lymph node involvement. Data were collected at baseline before the first or second chemotherapy cycle, during chemotherapy, at the first visit after chemotherapy (1 month), and at 6, 12, 18, and 24 months post-chemotherapy.

• A total of 210 participants were enrolled in the study.
• The median age was 50 years.
• The sample was 100% female.
• All participants had newly diagnosed breast cancer and were chemotherapy naïve. 
• All were receiving adjuvant chemotherapy. About 80% were receiving doxorubicin/cyclophosphamide with or without taxanes.
• 42% of the women were post-menopausal. 
• 94% of the women were Caucasian.

• Multi-site  
• Outpatient 
• 23 institutions in the United States

Participants were receiving active antitumor treatment.

Double-blind, randomized, placebo-controlled study

• High-Sensitivity Cognitive Screen (HSCS)
• Profile of Mood States (POMS)
• Cognitive subscale of the Perceived Health Scale (PHS)
• Common Terminology Criteria for Adverse Events (CTCAE) grading of adverse events
• Trail Making Test (TMT) A and B

No significant differences were seen between groups over 24 months in any study measures. All cognitive test scores improved from baseline to the first chemotherapy follow-up and then stabilized.

The study does not support the use of ginkgo biloba for prevention of cognitive impairment resulting from chemotherapy treatment in women with breast cancer.

• A risk of bias existed because of the very homogenous sample.
• The measurement validity and reliability was questionable because use of the same cognitive measures repeatedly could have resulted in improvement from practice effects.

Findings do not support the use of ginkgo biloba to prevent cognitive changes resulting from chemotherapy in patients with breast cancer.