Device to prevent nerve damage from chemotherapy in cancer patients
Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer
This study is testing a cooling device designed to help prevent nerve damage in cancer patients receiving chemotherapy, specifically those with gastrointestinal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corporacion Parc Tauli Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sabadell, Barcelona) |
| Trial ID | NCT06873360 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on a medical device aimed at preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer. It involves collecting data through patient interviews to co-design a prototype of a localized cooling device, likely in the form of gloves. The study seeks to understand patient experiences and usability patterns to optimize the device's design for future clinical investigations assessing its safety and efficacy. The goal is to enhance patient acceptance and identify profiles of patients who may benefit most from the device.
Who should consider this trial
Good fit: Ideal candidates are outpatient patients with gastrointestinal cancer who have undergone at least three cycles of oxaliplatin chemotherapy and are experiencing symptoms of peripheral neuropathy.
Not a fit: Patients with conditions such as osteoarthritis or autoimmune diseases affecting connective tissue may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the incidence of nerve damage caused by chemotherapy in gastrointestinal cancer patients.
How similar studies have performed: While this approach is innovative in its co-design methodology, similar studies have shown promise in developing supportive devices for chemotherapy-related side effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatient patient with gastrointestinal cancer treated with oxaliplatin. * Having completed at least three cycles of chemotherapy. * Presenting acute or chronic symptoms of chemotherapy-induced peripheral neuropathy. * The study will include individuals over 18 years old. Gender identify will be collected confidentially and inclusively, offering options for non-binary individuals and those who prefer not to identify with binary categories. Exclusion Criteria: * Patient with osteoarthritis or arthritis in the hands. * Diagnosis of any autoimmune disease affecting connective tissue, such as: rheumatoid arthritis, Raynaud's syndrome, lupus, scleroderma, dermatomyositis, vasculitis, or cryoglobulinemia.
Where this trial is running
Sabadell, Barcelona
- Consorci Corporació Sanitària Parc Taulí — Sabadell, Barcelona, Spain (Recruiting)
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.