Overview

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)