EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
Condition: Breast Cancer; Neurotoxicity
MeSH terms: Breast Neoplasms; Neurotoxicity Syndromes
Intervention: Ginkgo Biloba; Placebo
Intervention description: Patients will take 120 mg per day (60 mg BID); Patients will take 1 tablet BID
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 226.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neurotoxicity; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

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.
    

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)