Phase 3
N=226
EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
Breast Cancer · Neurotoxicity
Bottom Line
View on ClinicalTrials.gov: NCT00046891 ↗Enrolled (actual)
226
Serious AEs
3.4%
Results posted
Apr 2015
Primary outcome: Primary: The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. — 12.2; 12.6; 3.9; 2.6 units on a scale*months — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ginkgo Biloba (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. |
12.2; 12.6; 3.9; 2.6; 1.1; 0.7 | 0.84 |
| SECONDARY Median Scores for Trail Making Tests A and B (Lower Scores Are Better). |
30; 28; 25; 25; 24; 22 | — |
| SECONDARY Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. |
-4; -4; -6.5; -6.5; -5; -5 | — |
| SECONDARY Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) |
-0.5; -0.8; -0.1; -0.9; -0.4; -0.3 | — |
| SECONDARY Associations Between Self-reported Cognition and the HSCS. |
0.01; 0.08; -0.02; -0.06; 0.00; -0.02 | — |
| SECONDARY Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. |
-0.01; 0.05; -0.05; 0.04; .20; 0.10 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00046891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.