Medical Device for Oxaliplatin-Induced Neuropathy in Gastrointestinal Cancer Patients

NCT06873360 | Completed

• 1 other identifier: 2024/5114
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Keywords

Peripheral Neuropathy Induced by Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 6 months

Secondary Outcomes (3)

• Gain an in-depth understanding of the progression of OIPN 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.

  From baseline to 6 months

• Determine the design characteristics of the gloves.

  From baseline to 6 months

Study Arms (1)

Observational group of patients with gastrointestinal cancer treated with oxaliplatin.

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

Interventions

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.

Observational group of patients with gastrointestinal cancer treated with oxaliplatin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastrointestinal cancer treated with oxaliplatin chemotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 12, 2025
• Study Start: April 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

ES (1)