Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients

NCT ID: NCT06873360

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-10-30

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.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Observational group of patients with gastrointestinal cancer treated with oxaliplatin.

Clinical interviews with patients and Usability interviews and glove testing.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Sandra Soriano-Sánchez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Sandra Soriano Sánchez

Role: primary

ssorianosa@tauli.cat

+34 660043364

Other Identifiers

2024/5114

Identifier Type: -

Identifier Source: org_study_id