EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00046891

Purpose

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.

Condition	Intervention
Breast Cancer Neurotoxicity	Dietary Supplement: EGb761

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: EGB 761

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	220
Study Start Date:	December 2002
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed breast cancer
Planned standard doses of adjuvant chemotherapy with or without a taxane
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal status

Any status

Performance status

ECOG 0-1

Life expectancy

At least 6 months

Hematopoietic

No bleeding diathesis

Hepatic

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

See Disease Characteristics
No concurrent high-dose chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046891

Show 175 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Debra Barton, RN, PhD, AOCN

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000257008, NCCTG-N00C9, NCI-P02-0231
Study First Received:	October 3, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00046891 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

neurotoxicity
stage I breast cancer
stage II breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Neurotoxicity Syndromes
Poisoning
Disorders of Environmental Origin

Breast Neoplasms
Breast Diseases
Ginkgo

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Neurotoxicity Syndromes
Nervous System Diseases

Poisoning
Disorders of Environmental Origin
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009