Using ultrasound to detect nerve damage from oxaliplatin in cancer patients
A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
This study is testing if ultrasound can help find nerve damage caused by oxaliplatin in cancer patients with gastrointestinal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT03958747 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the effectiveness of ultrasound in identifying oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer. The study compares the cross-sectional area of tibial motor and sural sensory nerves in affected patients against historical data from healthy adults. Additionally, it explores correlations between ultrasound findings and nerve conduction studies, self-reported neuropathy scales, and skin biopsy results. The trial aims to enhance diagnostic methods for neuropathy related to chemotherapy treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with gastrointestinal or colorectal cancer who are currently or have previously received oxaliplatin-based chemotherapy and exhibit clinical symptoms of peripheral neuropathy.
Not a fit: Patients with a history of peripheral neuropathy prior to oxaliplatin treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of chemotherapy-induced neuropathy in cancer patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using ultrasound for nerve assessment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gastrointestinal cancer * Colorectal cancer (any stage) * Previously or currently receiving oxaliplatin -based chemotherapy. * Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -based therapy. * Ability and willingness to understand and sign an informed consent. Exclusion Criteria: * Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy. * Unable to provide history.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Roy Strowd, MD — Wake Forest University Health Sciences
- Study coordinator: Ashley Fansler, RN
- Email: arcarrol@wakehealth.edu
- Phone: 336-716-5440
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.