Peripheral Neuropathy Due to ChemotherapyNCT06873360
Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients
An observational study of Peripheral Neuropathy Due to Chemotherapy, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Clinical interviews with patients and Usability interviews and glove testing.
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastrointestinal cancer treated with oxaliplatin chemotherapy.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Clinical interviews with patients and Usability interviews and glove testing.
- Keywords
- Peripheral Neuropathy Induced by Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical interviews with patients and Usability interviews and glove testing.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational group of patients with gastrointestinal cancer treated with oxaliplatin. | Not described Receives: Other: Clinical interviews with patients and Usability interviews and glove testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-design a medical device with patients to develop a solution that can prevent the onset of oxaliplatin-induced peripheral neuropathy (OIPN)
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.
Measured: From baseline to 6 months
Secondary outcomes (3)
Gain an in-depth understanding of the progression of OIPN symptoms.
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.
Measured: 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.
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.
Measured: From baseline to 6 months
Determine the design characteristics of the gloves.
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.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Apr 2025
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Soriano-Sánchez, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873360
- Sponsor's protocol ID
- 2024/5114
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Medical Device for Oxaliplatin-Induced Peripheral Neuropathy Considering the Patient's Voice in Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT06873360
- Acronym / sponsor ID
- 2024/5114
- Keywords
- Peripheral Neuropathy Induced by Oxaliplatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group of patients with gastrointestinal cancer treated with oxaliplatin. | – | Other: Clinical interviews with patients and Usability interviews and glove testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastrointestinal cancer treated with oxaliplatin chemotherapy.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical interviews with patients and Usability interviews and glove testing.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. | Other | Observational group of patients with gastrointestinal cancer treated with oxaliplatin. |
Primary outcome
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.
3 secondary outcomes
Gain an in-depth understanding of the progression of OIPN symptoms.
Time frame: 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
Determine the design characteristics of the gloves.
Time frame: From baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy Due to Chemotherapy, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.