Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients

Corporacion Parc Tauli

Status: Enrolling

Conditions: Peripheral Neuropathy Due to Chemotherapy

Treatments: Other: Clinical interviews with patients and Usability interviews and glove testing.

Study type: Observational

Funder types: Other

Identifiers

NCT06873360

2024/5114

Details and patient eligibility

About

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 objective is to collect data through interviews with patients experiencing OIPN symptoms to co-design the medical device prototype, incorporating the patient's perspective. Additionally, the study aims to identify clinical and usability patterns that will help optimize the design of a future clinical investigation assessing the safety and efficacy of the final device.

Full 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, will enable the design of both the functional prototype and the future clinical research on safety and efficacy. This approach will increase the likelihood of patient acceptance of the medical device treatment and help identify different patient profiles that could benefit the most from it.

Secondary Hypotheses:

1. Patients will be able to easily adhere to the use of the device during chemotherapy.
2. The final glove design, in terms of materials and structure, will be suitable for commercial manufacturing and will have a viable demand among patients and healthcare providers.
3. There is no difference in treatment adherence between men and women or among people of different ages.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Observational group of patients with gastrointestinal cancer treated with oxaliplatin.

Treatment:

Other: Clinical interviews with patients and Usability interviews and glove testing.