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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Patients will take 120 mg per day (60 mg BID)
Patients will take 1 tablet BID
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.
Time frame: Baseline, 12 months after starting Chemotherapy.
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.
Time frame: Baseline, 1, 6, 12, 18 and 24 months time points
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).
Time frame: Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).
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Enrollment
226
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Santa Barbara Hematology Oncology - Lompoc
Lompoc, California, United States
Sansum Medical Clinic
Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
Santa Barbara, California, United States
Cancer Center of Santa Barbara
Snata Barbara, California, United States
Santa Barbara Hematology Oncology - Solvang
Solvang, California, United States
Aurora Presbyterian Hospital
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
...and 165 more locations
Time frame: Baseline, 1st evaluation of post chemotherapy.
Associations Between Self-reported Cognition and the HSCS.
Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.
Time frame: Baseline, 1, 6, 12, 18 and 24 months time points
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.
Time frame: Baseline, 1, 6, 12, 18 and 24 months time points