EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)

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)