egb761 in maintaining mental clarity in women receiving chemotherapy for newly diagnosed breast cancer

Conditions: Breast Cancer; Neurotoxicity

Summary: rationale: chemotherapy may cause memory loss, attention loss, and other problems that make it difficult for patients to think clearly. egb761 may help maintain mental clarity in patients undergoing chemotherapy. purpose: randomized clinical trial to study the effectiveness of egb761 in preventing loss of mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer.

objectives: * determine the effectiveness of egb761 in the prevention of chemotherapy-related cognitive dysfunction in women with breast cancer. * determine the safety and tolerability of this drug when administered during adjuvant chemotherapy in these patients. * assess the onset and trajectory of cognitive loss that may occur during chemotherapy in these patients. * assess the quality of life and cognitive role functioning of patients treated with this drug. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to type of chemotherapy (doxorubicin/cyclophosphamide vs doxorubicin/cyclophosphamide with taxane vs other anthracycline-based chemotherapy vs other non-anthracycline-based chemotherapy), age (18 to 49 vs 50 and over), menopausal status at start of therapy (premenopausal vs postmenopausal vs unknown for surgical reasons), and lymph node involvement (0-3 vs 4 or more). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral egb761 twice daily. * arm ii: patients receive oral placebo twice daily. patients in both arms receive treatment beginning no later than the start of the second course of chemotherapy and continuing until 1 month after the completion of chemotherapy. quality of life and cognitive function are assessed at baseline, monthly during chemotherapy, and then at 1, 6, 12, 18, and 24 months. patients are followed every 6 months for 2 years. projected accrual: a total of 220 patients (110 per treatment arm) will be accrued for this study within 11 months.

Eligibility criteria:
disease characteristics: * newly diagnosed breast cancer * planned standard doses of adjuvant chemotherapy with or without a taxane patient characteristics: age * 18 and over sex * female menopausal status * any status performance status * eastern cooperative oncology group (ecog) 0-1 life expectancy * at least 6 months hematopoietic * no bleeding diathesis hepatic * serum glutamate oxaloacetate transaminase (sgot) no greater than 1.5 times upper limit of normal (uln) * alkaline phosphatase no greater than 1.5 times uln renal * creatinine no greater than 1.5 times uln cardiovascular * no arterial vascular disease other * able to complete questionnaires alone or with assistance * no diabetes * no dementia * no diagnosis of a psychiatric disorder within the past 5 years that would preclude study compliance * no other significant comorbidity * no known allergy to ginkgo biloba * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * no concurrent stem cell transplantation chemotherapy * no concurrent high-dose chemotherapy other * more than 6 months since prior egb761 * no concurrent antithrombotic therapy (e.g., daily aspirin or anticoagulants) * anticoagulants used for central or peripheral line maintenance (i.e., warfarin 1 mg/day or heparin flushes) allowed * no concurrent dose-intensive regimens * no concurrent aspirin or aspirin-like medicines (e.g., indomethacin, ibuprofen, or some antihistamines or heparin or warfarin \[except as used above\]) * no concurrent regimen expected to cause thrombocytopenia * no concurrent trazodone, monoamine oxidase inhibitors, or thiazide diuretics (e.g., chlorothiazide, hydrochlorothiazide, indapamide, or metolazone)

Keywords: neurotoxicity stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer