Clinical trial · Interventional
EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction
NCT00046891CI-TRIAL-00022854completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ginkgo Biloba | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ginkgo Biloba
- description
- 120 mg per day (60 mg BID)
- interventionNames
- Drug: Ginkgo Biloba
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1 tablet BID
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
- timeFrame
- Baseline, 12 months after starting Chemotherapy.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.