Status:
RECRUITING
Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients
Lead Sponsor:
Corporacion Parc Tauli
Conditions:
Peripheral Neuropathy Due to Chemotherapy
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study related to a medical device designed for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with gastrointestinal cancer. The primary objecti...
Detailed Description
Main Hypothesis: The clinical data collected from patient interviews, along with their active participation in the co-design of the localized cooling medical device, likely in the form of gloves, wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06873360
Start Date
April 1 2025
End Date
October 30 2025
Last Update
May 8 2025
Active Locations (1)
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1
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208