Daily home-based TENS for painful CIPN: phase III confirmatory trial
Official title: A phase III confirmatory clinical trial of daily, wireless, home-based TENS for painful peripheral neuropathy
Funded at University of Rochester · NIH-11339044 · Data updated 2026-11-12
A big, multi-site study will test whether a home-based, wireless TENS device can relieve painful chemotherapy-induced peripheral neuropathy in cancer patients.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Rochester NIH-funded |
| Lab location | 1 site (Rochester, United States) |
| Project start | August 1, 2026 |
| Project end | July 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $2,197,287 |
| NIH project number | 1R01CA311018-01 |
| Project ID | NIH-11339044 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with chemotherapy-induced peripheral neuropathy experiencing painful CIPN symptoms, able to use a home TENS device and comply with study procedures.
✕Less likely to help
People whose CIPN symptoms are not responsive to TENS or who have contraindications to electrical stimulation may not experience benefit.
What this research studies
If you have CIPN from neurotoxic chemotherapy, this trial explores whether using a wireless, home-delivered TENS device daily can reduce pain and improve balance and sleep. It builds on a successful prior phase II study and will be conducted across NCORP sites in a large, blinded, placebo-controlled setup. Participants will use the device at home, report their symptoms, and complete assessments to determine if the treatment provides meaningful relief with minimal risks. The study focuses on adults with CIPN from cancers such as breast, gastrointestinal, lung, ovarian, or myeloma undergoing neurotoxic chemotherapy.
Why it matters
Potential benefit: Participants who benefit could experience reduced CIPN pain and improved daily functioning and sleep.
How similar studies have gone: A prior phase II trial suggested that TENS can relieve CIPN pain and supported the feasibility of a large phase III trial.
Where this research is happening
-
University of Rochester
Rochester, United States Active
Researchers
- Principal investigator: Gewandter, Jennifer — University of Rochester
- Study coordinator: Gewandter, Jennifer
Related research
Other NIH-funded projects on the same topics.
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Non-invasive, microscopic biomarkers to detect CIPN in chemotherapy patients
This grant aims to develop a non-invasive imaging method to measure nerve changes in patients undergoing chemotherapy to better understand and monitor chemotherapy-induced peripheral neuropathy (CIPN).
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Novel pain biomarker for neuropathy that could guide therapy
A study to develop and test a biomarker that reflects how well peripherally acting pain medicines work for people with painful peripheral neuropathy.
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Auricular vagus nerve stimulation to help HIV-related nerve pain in older adults
A new, non-invasive brain-nerve stimulation approach is being tested to help older adults living with HIV who have nerve pain.
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Longitudinal study of how body-sense relates to chemotherapy nerve damage
This study follows people with breast or gastrointestinal cancer and healthy controls to see if brain processing of body sensations contributes to chemotherapy-induced nerve damage.
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Understanding how early nerve excitement during chemotherapy leads to painful nerve damage
A cancer treatment study looks at why the nerve pain some patients get after paclitaxel may develop, by studying how nerves react during the infusion.
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A new screen for chemotherapy-related nerve problems in young children
A clinician-scientist at Yale is developing a child-friendly survey to quickly screen for nerve-related side effects from cancer treatment in kids from birth to age 5.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.