Breast Cancer, Neurotoxicity
Conditions
Keywords
neurotoxicity, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Brief 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.
Detailed description
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.
Interventions
DRUGGinkgo Biloba
Patients will take 120 mg per day (60 mg BID)
OTHERPlacebo
Patients will take 1 tablet BID
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Baseline, 12 months after starting Chemotherapy. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | Baseline, 1, 6, 12, 18 and 24 months time points | 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. | Baseline, 1, 6, 12, 18 and 24 months post chemotherapy. | 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) | Baseline, 1st evaluation of post chemotherapy. | 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. | Baseline, 1, 6, 12, 18 and 24 months time points | 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. | Baseline, 1, 6, 12, 18 and 24 months time points | 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. |
Countries
United States
Participant flow
Recruitment details
226 patients were enrolled to this study between October 2002 and October 2006. There were 14 cancellations and 2 ineligible patients removed from the analysis; these participants were randomized but withdrew before beginning any study interventions. Efficacy analyses use all patients that reported baseline and one value after baseline.
Participants by arm
| Arm | Count |
|---|---|
| Ginkgo Biloba Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID) | 113 |
| Placebo Placebo: Patients will take 1 tablet BID | 113 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 |
| Overall Study | Cancels | 5 | 9 |
| Overall Study | Ineligible | 1 | 1 |
| Overall Study | Withdrawal by Subject | 18 | 15 |
Baseline characteristics
| Characteristic | Ginkgo Biloba | Placebo | Total |
|---|---|---|---|
| Age, Customized Age < 50 | 55 participants | 54 participants | 109 participants |
| Age, Customized Age >= 50 | 58 participants | 59 participants | 117 participants |
| Region of Enrollment United States | 113 participants | 113 participants | 226 participants |
| Sex: Female, Male Female | 113 Participants | 113 Participants | 226 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 104 | 94 / 101 |
| serious Total, serious adverse events | 4 / 104 | 3 / 101 |
Outcome results
Primary
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.
Population: Efficacy analyses uses all patients that reported baseline and one value after baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Visual-motor | 1.1 units on a scale*months | Standard Deviation 1.29 |
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Attention/concentration | 2.2 units on a scale*months | Standard Deviation 3.59 |
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Language | 3.9 units on a scale*months | Standard Deviation 6.84 |
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Self-regulation | 2.4 units on a scale*months | Standard Deviation 2.14 |
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Spatial | 1.4 units on a scale*months | Standard Deviation 0.92 |
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Total | 20.7 units on a scale*months | Standard Deviation 19.59 |
| Ginkgo Biloba | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Memory | 12.2 units on a scale*months | Standard Deviation 9.18 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Total | 18.0 units on a scale*months | Standard Deviation 12.26 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Memory | 12.6 units on a scale*months | Standard Deviation 9.16 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Language | 2.6 units on a scale*months | Standard Deviation 2.72 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Visual-motor | 0.7 units on a scale*months | Standard Deviation 0.84 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Spatial | 1.3 units on a scale*months | Standard Deviation 0.92 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Attention/concentration | 1.8 units on a scale*months | Standard Deviation 2.16 |
| Placebo | The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. | Self-regulation | 2.0 units on a scale*months | Standard Deviation 2.1 |
Comparison: Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.p-value: 0.84t-test, 2 sided
Secondary
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
Population: Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ginkgo Biloba | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 18 months | 0.14 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 12 months | -0.02 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 1 month | 0.01 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 6 months | -0.06 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 24 months | -0.06 Pearson correlation coefficient |
| Placebo | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 12 months | 0.02 Pearson correlation coefficient |
| Placebo | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 1 month | 0.08 Pearson correlation coefficient |
| Placebo | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 6 months | 0.00 Pearson correlation coefficient |
| Placebo | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 18 months | 0.07 Pearson correlation coefficient |
| Placebo | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 24 months | -0.07 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 24 months | -0.10 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 18 months | -0.10 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 1 month | -0.02 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 12 months | -0.08 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-reported Cognition and the HSCS. | HSCS attention concentration at 6 months | -0.02 Pearson correlation coefficient |
Secondary
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
Population: Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 6 months | 0.09 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 18 months | 0.06 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 24 months | -0.01 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 18 months | 0.06 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 1 month | -0.08 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 6 months | 0.04 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 1 month | -0.01 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 12 months | 0.13 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 12 months | -0.09 Pearson correlation coefficient |
| Ginkgo Biloba | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 24 months | 0.00 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 18 months | 0.08 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 1 month | 0.05 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 6 months | .20 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 12 months | 0.03 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 24 months | -0.02 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 1 month | -0.02 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 6 months | 0.28 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 12 months | 0.16 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 18 months | 0.08 Pearson correlation coefficient |
| Placebo | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 24 months | -.05 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 18 months | 0.08 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 24 months | 0.00 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 6 months | 0.10 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 18 months | 0.10 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 12 months | 0.10 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 24 months | -0.02 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 6 months | 0.21 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 1 month | -0.05 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT B at 1 month | -0.06 Pearson correlation coefficient |
| Balance Checkbook | Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. | TMT A at 12 months | -0.01 Pearson correlation coefficient |
Secondary
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
Population: Secondary analyses uses all patients that reported data for all the time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: Baseline | 30 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 1 month | 25 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 6 months | 24 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 12 months | 23.5 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 18 months | 25 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 24 months | 23 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: Baseline | 48 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 1 month | 45 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 6 months | 41 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 12 months | 40 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 18 months | 44.5 seconds |
| Ginkgo Biloba | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 24 months | 40 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 18 months | 40 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: Baseline | 28 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: Baseline | 50 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 1 month | 25 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 12 months | 45 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 6 months | 22 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 1 month | 44 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 12 months | 25 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 24 months | 40 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 18 months | 23 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT B: 6 months | 42 seconds |
| Placebo | Median Scores for Trail Making Tests A and B (Lower Scores Are Better). | TMT A: 24 months | 21 seconds |
Secondary
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.
Population: Secondary analysis uses all patients that reported baseline and at least one post baseline time point data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 1st Visit Post Chemo TMT A Score from BL | -4 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 1st Visit Post Chemo TMT B Score from BL | -6.5 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 6mth Visit Post Chemo TMT A Score from BL | -5 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 6mth Visit Post Chemo TMT B Score from BL | -6.7 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 12mth Visit Post Chemo TMT A Score from BL | -5 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 12mth Visit Post Chemo TMT B Score from BL | -7 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 18mth Visit Post Chemo TMT A Score from | -3.8 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 18mth Visit Post Chemo TMT B Score from | -7 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 24mth Visit Post Chemo TMT A Score from | -7 seconds |
| Ginkgo Biloba | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 24mth Visit Post Chemo TMT B Score from | -5 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 18mth Visit Post Chemo TMT B Score from | -9 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 1st Visit Post Chemo TMT A Score from BL | -4 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 12mth Visit Post Chemo TMT B Score from BL | -3 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 1st Visit Post Chemo TMT B Score from BL | -6.5 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 24mth Visit Post Chemo TMT B Score from | -7 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 6mth Visit Post Chemo TMT A Score from BL | -5 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 18mth Visit Post Chemo TMT A Score from | -4 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 6mth Visit Post Chemo TMT B Score from BL | -8 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 24mth Visit Post Chemo TMT A Score from | -5 seconds |
| Placebo | Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. | Chg in 12mth Visit Post Chemo TMT A Score from BL | -2 seconds |
Secondary
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).
Time frame: Baseline, 1st evaluation of post chemotherapy.
Population: Secondary analyses uses all patients that reported data for baseline and post chemo visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Appetite loss | -0.5 units on a scale | Standard Deviation 2.9 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Nausea | -0.1 units on a scale | Standard Deviation 2.78 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Dizziness | -0.4 units on a scale | Standard Deviation 1.96 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Constipation | -0.7 units on a scale | Standard Deviation 2.77 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Headache | -0.6 units on a scale | Standard Deviation 2.13 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Diarrhea | -0.3 units on a scale | Standard Deviation 1.74 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Indigestion | 0 units on a scale | Standard Deviation 2.61 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Bruising | -0.4 units on a scale | Standard Deviation 2.33 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Overall QOL | -0.4 units on a scale | Standard Deviation 2.08 |
| Ginkgo Biloba | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Thinks memory affects QOL | 0.5 units on a scale | Standard Deviation 2.82 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Bruising | -0.9 units on a scale | Standard Deviation 2.42 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Appetite loss | -0.8 units on a scale | Standard Deviation 2.81 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Diarrhea | 0.0 units on a scale | Standard Deviation 2.1 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Nausea | -0.9 units on a scale | Standard Deviation 2.67 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Thinks memory affects QOL | -0.5 units on a scale | Standard Deviation 3.06 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Dizziness | -0.3 units on a scale | Standard Deviation 2.07 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Indigestion | -0.4 units on a scale | Standard Deviation 2.67 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Constipation | -0.9 units on a scale | Standard Deviation 2.68 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Overall QOL | -0.6 units on a scale | Standard Deviation 2.4 |
| Placebo | Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) | Headache | -1.2 units on a scale | Standard Deviation 2.31 |