Surgical gloves to prevent hand neuropathy from oxaliplatin

GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy

This trial will test whether wearing surgical gloves during oxaliplatin chemotherapy can prevent hand numbness and pain in adults with colon cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AC Camargo Cancer Center (other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07285356 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Small studies have suggested surgical gloves can reduce paclitaxel-induced hand neuropathy, but this approach has not been tested for oxaliplatin.

Eligibility 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 this trial is running

São Paulo, São Paulo

• 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

Conditions: Colon Cancer, Oxaliplatin-induced Peripheral Neuropathy, oxaliplatin-induced peripheral neuropathy, Peripheral Neuropathy, Oxaliplatin, Surgical Gloves, Body Mass Index, Sarcopenia