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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT00046891
First received: October 3, 2002
Last updated: March 31, 2015
Last verified: March 2015
  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 Phase
Breast Cancer
Neurotoxicity
Drug: Ginkgo Biloba
Other: Placebo
Phase 3

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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. [ Time Frame: Baseline, 12 months after starting Chemotherapy. ] [ Designated as safety issue: No ]
    The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.


Secondary Outcome Measures:
  • Median Scores for Trail Making Tests A and B (Lower Scores Are Better). [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months time points ] [ Designated as safety issue: No ]
    The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.

  • Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months post chemotherapy. ] [ Designated as safety issue: No ]
    TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).

  • Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) [ Time Frame: Baseline, 1st evaluation of post chemotherapy. ] [ Designated as safety issue: No ]
    Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).

  • Associations Between Self-reported Cognition and the HSCS. [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months time points ] [ Designated as safety issue: No ]
    Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.

  • Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. [ Time Frame: Baseline, 1, 6, 12, 18 and 24 months time points ] [ Designated as safety issue: No ]
    Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.


Enrollment: 226
Study Start Date: December 2002
Study Completion Date: December 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginkgo Biloba
120 mg per day (60 mg BID)
Drug: Ginkgo Biloba
Patients will take 120 mg per day (60 mg BID)
Placebo Comparator: Placebo
1 tablet BID
Other: Placebo
Patients will take 1 tablet BID

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

  • 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

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT00046891     History of Changes
Other Study ID Numbers: NCCTG-N00C9, NCI-2012-02492, NCI-P02-0231, CDR0000257008
Study First Received: October 3, 2002
Results First Received: February 25, 2015
Last Updated: March 31, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Breast Diseases
Chemically-Induced Disorders
Neoplasms
Neoplasms by Site
Nervous System Diseases
Poisoning
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2015