Improving balance in older breast cancer survivors using neuromodulation
Neuromodulation of Central Sensory Integration to Improve Postural Control: a Pilot Study in Older Women with Breast Cancer
This study is testing if a brain stimulation technique can help older breast cancer survivors improve their balance after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, cyclophosphamide |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06610617 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of neuromodulation on sensory integration to enhance balance performance in older breast cancer survivors who have undergone taxane chemotherapy. Participants will undergo transcranial direct current stimulation (tDCS) to modify the excitability of the prefrontal cortex (PFC) and assess its immediate impact on balance through a sensory organization test. The study will also measure cognitive function and the severity of chemotherapy-induced peripheral neuropathy (CIPN). A total of 20 participants aged 60-85 will be recruited to ensure a homogeneous group regarding cancer treatment history.
Who should consider this trial
Good fit: Ideal candidates are women aged 60-85 who are breast cancer survivors and have completed taxane chemotherapy.
Not a fit: Patients with significant gait disorders or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve balance and reduce fall risk in older breast cancer survivors.
How similar studies have performed: While the specific application of tDCS for this population is novel, similar neuromodulation approaches have shown promise in improving balance and cognitive function in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria for breast cancer survivors: * Women aged 60-85 years * Breast cancer survivors, stages I-IIIc * Completion of taxane chemotherapy treatment. Taxane combined with a history of anthracycline and/or cyclophosphamide is permitted. Active anti-estrogen therapy is permitted. Receiving platin based agents is permitted. * Ability to walk without an assistive device * Ability to speak and read English * Without neurological disease, aside from chemotherapy induced peripheral neuropathy (CIPN) or chemotherapy related cognitive dysfunction (CRCD) * No history of a second cancer * Own a device with capability to sync the Fitbit Exclusion criteria for cancer survivors: * Inability to stand or walk unassisted for 60 seconds * 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. Cognitive status assessed via the Telephone Interview of Cognitive Status (mTICS). We will exclude those with marked dementia (score below 31). * Chronic vertigo * Myocardial infarction within the past six months * History of platin chemotherapy * History of immunotherapy * Any history of brain or spine surgery, known hearing, visual, or vestibular impairment * Active chemotherapy, radiation, or immunotherapy * Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past five years, active use of neuro-active drugs, metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp. * Currently taking anti-epileptic medication
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Brendan McNeish, MD — University of Pittsburgh
- Study coordinator: Lauren Wilcox, CCRP
- Email: ljk37@pitt.edu
- Phone: 412-648-6848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.