Surgical gloves to prevent hand neuropathy from oxaliplatin
Official title: GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
Run by AC Camargo Cancer Center · NCT07285356 · Data updated 2026-11-12
This trial will test whether wearing surgical gloves during oxaliplatin chemotherapy can prevent hand numbness and pain in adults with colon cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | October 6, 2025 |
| Main results expected | September 18, 2026 |
| Study ends | September 18, 2026 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07285356 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with colon adenocarcinoma treated with oxaliplatin-based chemotherapy (high‑risk stage III or stage IV), ECOG 0–1, without pre-existing neuropathy, uncontrolled diabetes, or glove allergy are ideal candidates.
✕Probably not a fit
Patients with pre-existing neuropathy, uncontrolled diabetes, known glove allergy, prior exposure to oxaliplatin or taxanes, or primarily foot neuropathy may not receive benefit from this hand-focused intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized trial comparing the use of surgical gloves during oxaliplatin infusions versus usual care to prevent hand-directed oxaliplatin-induced peripheral neuropathy. The primary endpoint is the occurrence of grade 2 or higher hand neuropathy as measured by CTCAE v5.0 and patient-reported PRO-CTCAE. Eligible patients are adults with colon adenocarcinoma receiving oxaliplatin-based regimens (high-risk stage III or stage IV) with ECOG 0–1 and no pre-existing neuropathy or glove allergy. The intervention is administered at A.C. Camargo Cancer Center and participants are followed for neuropathy outcomes during treatment.
Why it matters
Potential benefit: If successful, wearing surgical gloves during infusions could reduce moderate-to-severe hand neuropathy and help preserve daily function and quality of life.
How similar studies have gone: Small studies have suggested surgical gloves can reduce paclitaxel-induced hand neuropathy, but this approach has not been tested for oxaliplatin.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pre-existing neuropathy. * Uncontrolled diabetes. * known glove allergies. * Prior treatment with paclitaxel, docetaxel or oxaliplatin.
Where it's running
-
A.C. Camargo Cancer Center
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Éverton Germano Melo, Medical Doctor — Londrina Cancer Hospital
- Study coordinator: Virgilio Souza Silva, Medical Doctor, PhD
- Email: virss2013@gmail.com
- Phone: +55 (11) 2189-5000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.