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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Neurotoxicity

Treatments: Other: Placebo; Drug: Ginkgo Biloba

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00046891

NCI-P02-0231

NCI-2012-02492 (Registry Identifier)

CDR0000257008 (Registry Identifier)

NCCTG-N00C9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

226 participants in 2 patient groups, including a placebo group

Ginkgo Biloba

Experimental group

Description:

120 mg per day (60 mg BID)

Treatment:

Drug: Ginkgo Biloba

Placebo

Placebo Comparator group

Description:

1 tablet BID

Treatment:

Other: Placebo