About this trial
This clinical trial tests the effect of transcranial direct current stimulation (tDCS) to improve gait in older breast cancer survivors who received taxane and/or platinum chemotherapy. Chemotherapy, especially taxane or platinum therapy, can cause damage to the to the nerves resulting in numbness, tingling and pain, which can cause difficulty walking. It can also cause cognitive dysfunction which may effect gait. TDCS is a non-invasive brain stimulation device which uses a very mild electrical current applied to the scalp to temporarily stimulate a specific area of the brain involved in thinking and movement which may improve walking, particularly while doing two things at once. TDCS may be effective in improving gait for older breast cancer survivors who received taxane and/or platinum chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 60-85 years
Breast cancer survivors, stages I-IV without clinical suspicion or evidence of brain metastasis
Completion of last taxane and/or platinum chemotherapy treatment ≥ 6 months prior, but chemotherapy was received after the age of 60. Taxane combined with a history of platinum, anthracycline and/or cyclophosphamide is permitted. Active anti-estrogen therapy, Anti-HER2, and CDK 4/6 inhibitors are permitted
Ability to walk unassisted for 60 seconds
Disqualifiers
Hospitalization within the past three months due to acute illness or as the result of a musculoskeletal injury significantly affecting gait or balance
Any unstable medical condition
Diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder
Chronic vertigo
Trial design
Crossover
Treatments tested in this trial
Sham Intervention
Procedure/SurgeryReceive sham tDCS
Survey Administration
Other interventionAncillary studies
Transcranial Direct Current Stimulation
DeviceReceive tDCS
Treatment groups
Trial outcomes
Primary outcomes
Dual task gait speed cost
This cost will be operationalized as the absolute and percent change in gait metrics (time to walk/variability) during dual-task walking relative to walking without a secondary task. Cost will be defined as (\[speed dual task - speed single task\]/speed single task\] \*100). Will fit a series of linear mixed models with each of the dual task costs, prefrontal cortex activation, and executive function measures as the dependent variables; sequence, period, and treatment as fixed effects of interest; baseline values as fixed effect covariates; and a participant-within sequence random effect.
Secondary outcomes
Dual task cost to gait speed
Will fit a series of analyses of covariance models with each gait single task and dual-task cost measure as the dependent variable; group (older, taxane-treated female breast cancer survivors versus non-cancer historical control group) as the factor of interest; and other measures of interest (age, proprioception, grip strength, depression, and pain) or other variables different between groups as covariates.
Prefrontal hemodynamic response
Assessed via functional near-infrared spectroscopy during dual task gait speed. Will fit a series of linear mixed models with each measure of prefrontal cortex activation as the dependent variable; group (older, taxane-treated female breast cancer survivors versus non-cancer historical control group), task (single/dual), and their interaction as fixed effects; covariates as additional fixed effects; and a participant random effect.
Sponsors and contacts
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University of Michigan Rogel Cancer Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
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