GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients aged 18 years or older who have provided written informed consent.
• Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV.
• Oxaliplatin-based treatment in the context of localized or metastatic disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Locations
Other Locations
Brazil
A.C. Camargo Cancer Center
RECRUITING
São Paulo
Contact Information
Primary
Virgilio Souza Silva, Medical Doctor, PhD
virss2013@gmail.com
+55 (11) 2189-5000
Backup
Éverton Germano Melo, Medical Doctor
evertongermanomelo@gmail.com
+55 (43) 3379-2600
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2026-09-18
Participants
Target number of participants: 84
Treatments
Experimental: Surgical Gloves
During each chemotherapy cycle, patients in the experimental arm will wear compressive surgical gloves (0.5 size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion.
No_intervention: No Surgical Gloves
The control arm will receive treatment according to current recommendations without the use of any devices on the hands.
Related Therapeutic Areas
Sponsors
Leads: AC Camargo Cancer Center
Collaborators: Hospital do Cancer de Londrina