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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00046891
First received: October 3, 2002
Last updated: February 26, 2010
Last verified: February 2010
  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: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction

Resource links provided by NLM:


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
Investigators
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00046891     History of Changes
Other Study ID Numbers: CDR0000257008, NCCTG-N00C9, NCI-P02-0231
Study First Received: October 3, 2002
Last Updated: February 26, 2010
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

Additional relevant MeSH terms:
Breast Neoplasms
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nervous System Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 16, 2014