EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction|
- The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. [ Time Frame: Baseline, 12 months after starting Chemotherapy. ] [ Designated as safety issue: No ]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.
- Median Scores for Trail Making Tests A and B (Lower Scores Are Better). [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months time points ] [ Designated as safety issue: No ]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.
- Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months post chemotherapy. ] [ Designated as safety issue: No ]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).
- Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) [ Time Frame: Baseline, 1st evaluation of post chemotherapy. ] [ Designated as safety issue: No ]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).
- Associations Between Self-reported Cognition and the HSCS. [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months time points ] [ Designated as safety issue: No ]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.
- Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months time points ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2002|
|Study Completion Date:||April 2015|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Experimental: Ginkgo Biloba
120 mg per day (60 mg BID)
Drug: Ginkgo Biloba
Patients will take 120 mg per day (60 mg BID)
Placebo Comparator: Placebo
1 tablet BID
Patients will take 1 tablet BID
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046891
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|Study Chair:||Debra Barton, RN, PhD, AOCN, FAAN||Mayo Clinic|