Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients
March 7, 2026 updated by: Sandra Soriano-Sánchez, Corporacion Parc Tauli
Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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:
- Patients will be able to easily adhere to the use of the device during chemotherapy.
- 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.
- There is no difference in treatment adherence between men and women or among people of different ages.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Consorci Corporació Sanitària Parc Taulí
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with gastrointestinal cancer treated with oxaliplatin chemotherapy.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational group of patients with gastrointestinal cancer treated with oxaliplatin.
|
Clinical interviews with patients: These will be conducted by nursing staff with an approximate total of 50 patients during their treatment at the Hospital. Each interview will last 15 minutes. Under no circumstances will the patient be required to answer any question. Usability interviews and glove testing: 10 patients selected from the previous interviews will test different gloves with various textures and levels of stiffness. Additionally, other questions will be asked focusing on refining the design. This evaluation will help determine the most suitable materials for the device's manufacturing, achieving a balance between comfort, discretion and functionality. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Co-design a medical device with patients to develop a solution that can prevent the onset of oxaliplatin-induced peripheral neuropathy (OIPN)
Time Frame: From baseline to 6 months
|
Interviews will be conducted with patients to gather information on the clinical presentation of oxaliplatin-induced peripheral neuropathy and its impact on patients' quality of life.
|
From baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gain an in-depth understanding of the progression of OIPN symptoms.
Time Frame: From baseline to 6 months
|
It consists of understanding the evolution of symptoms of oxaliplatin-induced peripheral neuropathy through quality of life questionnaires.
These quality of life questionnaires will include questions related to intensity, location, triggers, and recurrence of these symptoms.
|
From baseline to 6 months
|
|
Ensure the usability of the device by assessing the patient's ability to adhere to treatment with a medical device.
Time Frame: From baseline to 6 months
|
The patients will try different gloves with various textures and levels of stiffness.
Additionally, other questions different from those in the main study will be asked, focusing more on refining the design.
This evaluation will help determine the most suitable materials for the device's manufacturing, achieving a balance between comfort, discretion, and functionality.
|
From baseline to 6 months
|
|
Determine the design characteristics of the gloves.
Time Frame: From baseline to 6 months
|
The patients will receive three different designs of non-functional commercial gloves (which do not generate cold or heat through electronics).
In some cases, these gloves may have been modified to exhibit certain properties (such as texture, breathability, or thickness).
Additionally, different sizes will be available for each model to ensure a proper fit for the patient's hand.
|
From baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Actual)
November 30, 2025
Study Completion (Actual)
December 30, 2025
Study Registration Dates
First Submitted
February 15, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 12, 2025
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 7, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/5114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.