Using neuromodulation to treat pain from chemotherapy-induced peripheral neuropathy
Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
This study is testing a new way to relieve pain from nerve damage caused by chemotherapy in patients with lower extremity CIPN.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06121232 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of neuromodulation in alleviating pain associated with chemotherapy-induced peripheral neuropathy (CIPN). It will involve patients diagnosed with lower extremity CIPN due to specific chemotherapy agents, who will undergo sensory testing and evaluation of peripheral neuropathy markers. The study will take place at the Pain Management Center at MD Anderson Cancer Center, focusing on a single-center feasibility approach. Participants will be monitored for changes in pain levels and nerve function as a result of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 who have been diagnosed with lower extremity CIPN due to specific chemotherapy treatments.
Not a fit: Patients with cognitive dysfunction, recent substance abuse, or preexisting peripheral neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve quality of life for patients suffering from CIPN.
How similar studies have performed: While neuromodulation has shown promise in other pain management studies, this specific application for CIPN is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds * Patients seen at Pain Management Center at MD Anderson Cancer Center * Patient ages greater or equal to 18 years but less than or equal to 85 years Exclusion Criteria * Patients with cognitive dysfunction * Patient with recent history (\<6 months) of drug or alcohol abuse * Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection * Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Saba Javed, M D — M.D. Anderson Cancer Center
- Study coordinator: Saba Javed, M D
- Email: sjaved@mdanderson.org
- Phone: (713) 792-9530
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.