A Randomized, Sham Controlled, Double Blinded, Crossover Mechanistic Trial of the Impact of Transcranial Direct Current to the Left Dorsolateral Prefrontal Cortex on Gait in Older Breast Cancer Survivor's Post-Taxane Chemotherapy
| Registry | NCT07864792 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, supportive care |
| Enrollment | 60 (Estimated) |
| Sponsor | University of Michigan Rogel Cancer Center (Other); collaborators: National Institute on Aging (NIA) |
| Conditions | Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 |
| Interventions | Sham Intervention, Survey Administration, Transcranial Direct Current Stimulation (Procedure, other, device) |
| Dates | start 2026-09-01 (estimated), primary completion 2029-09-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-10-08, last updated 2026-10-08 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Anatomic Stage I Breast Cancer AJCC v8 All trials for Anatomic Stage II Breast Cancer AJCC v8 All trials of Sham Intervention All trials of Survey Administration
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm I: tDCS first, followed by sham | Experimental | Procedure: Sham Intervention; Other: Survey Administration; Device: Transcranial Direct Current Stimulation | Patients receive tDCS, over 20 minutes. One week later patients crossover to receive sham |
| Arm II (sham tDCS followed by tDCS) | Experimental | Procedure: Sham Intervention; Other: Survey Administration; Device: Transcranial Direct Current Stimulation | Patients receive sham tDCS, over 20 minutes. One week later patients crossover to receive treatment with actual tDCS |
Sex: Female, ages: 60 Years to 85 Years
Inclusion Criteria: * 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 * Proficient in English * Without neurological disease, aside from chemotherapy induced peripheral neuropathy (CIPN) or chemotherapy related cognitive dysfunction (CRCD) * No history of a second cancer besides skin cancer Exclusion Criteria: * 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 * Myocardial infarction within the past six months * History of immune check point inhibitor therapy * Any history of brain or cervical spine surgery, known hearing, visual, or vestibular impairment * Active neurotoxic chemotherapy (taxane, platinum or vinca alkaloid) or radiation therapy * Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past two years,, metal objects in head or neck, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, cochlear implant, vagus nerve stimulator, spinal cord stimulator, pacemakers, and intracardiac devices, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
| Facility | City | Country | Status |
|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor, Michigan | United States |
NIH grants: K23AG090624