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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
23/10/2018
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
Scientific title
Efficacy and safety of Ginkgo Biloba for cognitive function and fatigue in breast cancer patients after primary adjuvant treatment
Secondary ID [1] 1374 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 237219 0
Cognitive function 237220 0
Condition category
Condition code
Cancer 237537 237537 0 0
Breast
Alternative and Complementary Medicine 237538 237538 0 0
Herbal remedies
Mental Health 256906 256906 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 236916 0
Treatment: Other
Intervention code [2] 255969 0
Prevention
Comparator / control treatment
Placebo capsule containing microcellulose powder
Dose: 240 mg (2x120 mg) inactive encapsulated tablets taken daily
Duration: 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 238347 0
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
Timepoint [1] 238347 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [1] 244767 0
Fatigue assessed using the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire.
Timepoint [1] 244767 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [2] 244768 0
Self-report cognitive function assessed using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire
Timepoint [2] 244768 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [3] 244769 0
Anxiety assessed using the General Health Questionnaire (GHQ)
Timepoint [3] 244769 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [4] 244770 0
Depression assessed using the General Health Questionnaire (GHQ)
Timepoint [4] 244770 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [5] 244771 0
Perceived stress assessed using the Perceived Stress Questionnaire
Timepoint [5] 244771 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [6] 244772 0
Quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Timepoint [6] 244772 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [7] 244773 0
Toxicity using the NCI Common Terminology Criteria for Adverse Events v3.0 grading system.
Timepoint [7] 244773 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [8] 244774 0
Menopausal symptoms using the Functional Assessment of Cancer Therapy - Endocrine symptoms (FACT-ES) questionnaire
Timepoint [8] 244774 0
Baseline, 6, and 12 months post-randomisation
Secondary outcome [9] 244775 0
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)
Timepoint [9] 244775 0
Baseline, 6, and 12 months post-randomisation

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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic balancing (minimisation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12234 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 12235 0
Mater Sydney - North Sydney
Recruitment hospital [3] 12236 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [4] 12237 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 12238 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 12239 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [7] 12240 0
Strathfield Private Hospital - Strathfield
Recruitment postcode(s) [1] 1889 0
2139
Recruitment postcode(s) [2] 1890 0
2050
Recruitment postcode(s) [3] 24420 0
2139 - Concord
Recruitment postcode(s) [4] 24421 0
2060 - North Sydney
Recruitment postcode(s) [5] 24422 0
2200 - Bankstown
Recruitment postcode(s) [6] 24423 0
2560 - Campbelltown
Recruitment postcode(s) [7] 24424 0
2170 - Liverpool
Recruitment postcode(s) [8] 24425 0
2050 - Camperdown
Recruitment postcode(s) [9] 24426 0
2135 - Strathfield

Funding & Sponsors
Funding source category [1] 237314 0
Charities/Societies/Foundations
Name [1] 237314 0
Cancer Australia
Address [1] 237314 0
PO Box 1201
Dickson ACT 2602
Country [1] 237314 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Clinical Trials Office
Sydney Medical School
Edward Ford Building (A27)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 255776 0
None
Name [1] 255776 0
Address [1] 255776 0
Country [1] 255776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239409 0
Sydney South West Area Health Service - Concord Hospital Zone
Ethics committee address [1] 239409 0
Research Development Office
Building 76
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
Ethics committee country [1] 239409 0
Australia
Date submitted for ethics approval [1] 239409 0
22/11/2007
Approval date [1] 239409 0
24/04/2008
Ethics approval number [1] 239409 0
07/CRGH/91

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.
Trial website
N/A
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 29888 0
Prof Janette Vardy
Address 29888 0
Sydney Cancer Centre Concord Repatriation General Hospital Hospital Rd Concord NSW 2139
Country 29888 0
Australia
Phone 29888 0
61 2 9767 5000
Fax 29888 0
Email 29888 0
janette.vardy@sydney.edu.au
Contact person for public queries
Name 13135 0
Dr Haryana Dhillon
Address 13135 0
Centre for Medical Psychology & Evidence-based Decision-making, Central Clinical School, Chris O'Brien Lifehouse, University of Sydney NSW 2006
Country 13135 0
Australia
Phone 13135 0
61 2 9036 5392
Fax 13135 0
61 2 9036 5292
Email 13135 0
haryana.dhillon@sydney.edu.au
Contact person for scientific queries
Name 4063 0
Prof Janette Vardy
Address 4063 0
Sydney Cancer Centre
Concord Repatriation General Hospital
Hospital Rd
Concord NSW 2139
Country 4063 0
Australia
Phone 4063 0
61 2 9767 5000
Fax 4063 0
Email 4063 0
janette.vardy@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results