Efficacy and safety of Ginkgo Biloba for cognitive function and fatigue in breast cancer patients after primary adjuvant treatment

Phase 3

• Conditions: Cognitive function; Cancer - Breast; Mental Health - Studies of normal psychology, cognitive function and behaviour; Breast Cancer; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12610000121066
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-05
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 72

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive function (objectively measured) assessed using a battery of standardised, validated neuropsychological tests:<br>Wide Range Achievement Test (WRAT) 3 Reading test (baseline only)<br>Controlled Oral Word Association Test (COWAT), Thurstone Word Fluent Test, Category animal fluency, Trail Making A & B,<br>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[Baseline, 6, and 12 months post-randomisation]