Clinical trial NCT06873360: Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients
Official title: Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Neuropathy Due to Chemotherapy
Keywords: Peripheral Neuropathy Induced by Oxaliplatin
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal cancer treated with oxaliplatin chemotherapy.

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 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.

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, 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.

Eligibility 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.

Primary outcomes:
measure: Co-design a medical device with patients to develop a solution that can prevent the onset of oxaliplatin-induced peripheral neuropathy (OIPN)
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Gain an in-depth understanding of the progression of OIPN symptoms.
timeFrame: From baseline to 6 months
measure: Ensure the usability of the device by assessing the patient's ability to adhere to treatment with a medical device.
timeFrame: From baseline to 6 months
measure: Determine the design characteristics of the gloves.
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
References: