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Trial registered on ANZCTR
Registration number
ACTRN12610000121066
Ethics application status
Approved
Date submitted
11/07/2009
Date registered
5/02/2010
Date last updated
10/09/2020
Date data sharing statement initially provided
10/09/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy and safety of Ginkgo Biloba for cognitive function and fatigue in breast cancer patients after primary adjuvant treatment
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Scientific title
Efficacy and safety of Ginkgo Biloba for cognitive function and fatigue in breast cancer patients after primary adjuvant treatment
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Secondary ID [1]
1374
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Cognitive function
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Condition category
Condition code
Cancer
237537
237537
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0
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Breast
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Alternative and Complementary Medicine
237538
237538
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0
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Herbal remedies
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Mental Health
256906
256906
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Ginkgo Biloba (standardised extract EGB 761) encapsulated tablets
Dose: 240 mg (2x120 mg) encapsulated tablets taken daily
Duration: 6 months
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Intervention code [1]
236916
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Treatment: Other
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Intervention code [2]
255969
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Prevention
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Comparator / control treatment
Placebo capsule containing microcellulose powder
Dose: 240 mg (2x120 mg) inactive encapsulated tablets taken daily
Duration: 6 months
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Cognitive function (objectively measured) assessed using a battery of standardised, validated neuropsychological tests:
Wide Range Achievement Test (WRAT) 3 Reading test (baseline only)
Controlled Oral Word Association Test (COWAT), Thurstone Word Fluent Test, Category animal fluency, Trail Making A & B,
Wisconsin Cord sorting (64 item), Stroop, Digit symbol, Reaction time test - from CANTAB, Digit Span, Letter Number Sequence, Spatial Span, Hopkins Verbal Learning test, Brief Visuospatial Memory Test, Grooved pegboard
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Assessment method [1]
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Timepoint [1]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [1]
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Fatigue assessed using the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire.
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Assessment method [1]
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Timepoint [1]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [2]
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Self-report cognitive function assessed using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire
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Assessment method [2]
244768
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Timepoint [2]
244768
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [3]
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Anxiety assessed using the General Health Questionnaire (GHQ)
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Assessment method [3]
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Timepoint [3]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [4]
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Depression assessed using the General Health Questionnaire (GHQ)
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Assessment method [4]
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Timepoint [4]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [5]
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Perceived stress assessed using the Perceived Stress Questionnaire
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Assessment method [5]
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Timepoint [5]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [6]
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Quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
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Assessment method [6]
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Timepoint [6]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [7]
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Toxicity using the NCI Common Terminology Criteria for Adverse Events v3.0 grading system.
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Assessment method [7]
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Timepoint [7]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [8]
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Menopausal symptoms using the Functional Assessment of Cancer Therapy - Endocrine symptoms (FACT-ES) questionnaire
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Assessment method [8]
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Timepoint [8]
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Baseline, 6, and 12 months post-randomisation
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Secondary outcome [9]
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Biomarkers:
- Full Blood Count (FBC) including differential
- Creatinine, urea and electrolytes
- Liver Function Tests (LFT) : bilirubin, alanine transaminase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH)
- Cytokines & inflammatory markers: Interleukin (IL)-1Beta, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, tumor necrosis factor-alpha (TNF-alpha), interferon (IFN-gamma), granulocyte-macrophage colony stimulating factor (GM-CSF), vascular endothelial growth factor (VEG-F), C reactive protein (CRP) and IL-1R
- Sex hormones: oestradiol, LH, FSH
- Blood clotting parameters: Thrombin-anti-thrombin complex (TAT), prothrombin fragment-1 &-2, d-dimers, homocysteine
- Apolipoprotein E genotype (baseline only)
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Assessment method [9]
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Timepoint [9]
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Baseline, 6, and 12 months post-randomisation
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Eligibility
Key inclusion criteria
Diagnosis of invasive breast cancer for which definitive surgery was performed.
Patient has completed chemotherapy and/or radiotherapy and/or targeted therapy for adjuvant treatment (if received) for breast cancer at least six months previously. Patients who did not require chemotherapy are eligible but must be at least six months post surgery and radiotherapy.
Patient has completed at least 2 months of anti-cancer hormonal treatment (if received).
Patient is less than two years post completing primary adjuvant treatment.
Self report cognitive symptoms based on a Single Item Question assessing their subjective change in cognitive function since their cancer diagnosis. Participants must select one of three possible responses (yes, no, unknown) to the question: “Do you think your brain is working as well as it was before your cancer diagnosis?” To meet eligibility, participants must choose the “NO” response.
Speak fluent English and read to at least year 8 standard;
Written informed consent;
Accessible for treatment and follow-up
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status < or = 2;
Any evidence of extra-nodal metastatic disease;
Any major pre-existing psychiatric history or dementia, alcohol abuse, current use of psychotropic medication that might lead to cognitive problems other than benzodiazepines for nausea or sleep or selective serotonin reuptake inhibitor (SSRI) for hot flashes;
Pre-existing neurological condition or any other co-morbidity which may interfere with their ability to perform cognitive testing;
Previous chemotherapy for a malignancy.
Life expectancy < 2years;
use of Ginkgo biloba within 4 weeks of randomisation;
Any contraindication to taking ginkgo biloba.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting subjects will be randomised via central, online randomisation system. Treatment allocation will be carried out within the system after stratification of subjects.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic balancing (minimisation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/04/2010
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Actual
25/05/2015
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Date of last participant enrolment
Anticipated
30/12/2019
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Actual
31/05/2019
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Date of last data collection
Anticipated
30/12/2020
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Actual
6/03/2020
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Sample size
Target
72
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Concord Repatriation Hospital - Concord
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Recruitment hospital [2]
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Mater Sydney - North Sydney
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Recruitment hospital [3]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [4]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [5]
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Liverpool Hospital - Liverpool
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Recruitment hospital [6]
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The Chris O’Brien Lifehouse - Camperdown
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Recruitment hospital [7]
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Strathfield Private Hospital - Strathfield
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Recruitment postcode(s) [1]
1890
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2050
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2060 - North Sydney
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Recruitment postcode(s) [4]
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2135 - Strathfield
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Recruitment postcode(s) [5]
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2139
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Recruitment postcode(s) [6]
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2139 - Concord
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Recruitment postcode(s) [7]
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2170 - Liverpool
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Recruitment postcode(s) [8]
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2200 - Bankstown
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Recruitment postcode(s) [9]
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2560 - Campbelltown
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Cancer Australia
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Address [1]
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PO Box 1201
Dickson ACT 2602
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
Clinical Trials Office
Sydney Medical School
Edward Ford Building (A27)
University of Sydney NSW 2006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
255776
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney South West Area Health Service - Concord Hospital Zone
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Ethics committee address [1]
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Research Development Office Building 76 Concord Repatriation General Hospital Hospital Rd Concord NSW 2139
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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22/11/2007
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Approval date [1]
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24/04/2008
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Ethics approval number [1]
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07/CRGH/91
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Summary
Brief summary
This study looks at the effectiveness and safety of treatment with the herb ginkgo biloba in preventing or reducing changes in thinking, memory and concentration (cognitive function) experienced by some women after treatment for early breast cancer. Who is it for? You can join this study if you have been diagnosed with early invasive breast cancer and you have had surgery for this, and have completed primary adjuvant treatment. What does it involve? Participants will be divided into two groups. One group will receive treatment with standardized extracts of the herb ginkgo biloba. The other group will receive a non-active compound (placebo). Both groups will take two tablets (120mg) of study treatment each day for a period of 6 months. All participants will have their cognitive function monitored, along with fatigue, quality of life, blood tests, other possible symptoms, Assessments are at baseline, 6 and 12 months after randomization. Each assessment will take approximately 90 minutes. Most women who receive chemotherapy become tired; some complain of memory & concentration problems. Studies have found subtle cognitive impairment ("chemobrain") that can disturb the return to a normal life and there are no known treatments. Ginkgo biloba has been shown to improve cognition in healthy younger volunteers & improve cognition & mood, without side effects, in elderly people.
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Trial website
N/A
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Trial related presentations / publications
Nil to date
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Public notes
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Contacts
Principal investigator
Name
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Prof Janette Vardy
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Address
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Sydney Cancer Centre Concord Repatriation General Hospital Hospital Rd Concord NSW 2139
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Country
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Australia
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Phone
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61 2 9767 5000
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Fax
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Email
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janette.vardy@sydney.edu.au
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Contact person for public queries
Name
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Haryana Dhillon
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Address
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Centre for Medical Psychology & Evidence-based Decision-making, Central Clinical School, Chris O'Brien Lifehouse, University of Sydney NSW 2006
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Country
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Australia
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Phone
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61 2 9036 5392
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Fax
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61 2 9036 5292
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Email
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haryana.dhillon@sydney.edu.au
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Contact person for scientific queries
Name
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Janette Vardy
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Address
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Sydney Cancer Centre
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
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Country
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Australia
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Phone
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61 2 9767 5000
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Fax
4063
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Email
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janette.vardy@sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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