Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy (GLOX-PEN)

December 2, 2025 updated by: Virgilio Souza e Silva, AC Camargo Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal tumors account for one-quarter of the global cancer incidence and one-third of cancer-related deaths. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of oxaliplatin-based treatments. CIPN can lead to an extremely painful and debilitating process, causing significant loss of functional abilities and negatively affecting the quality of life of these patients, as well as activities of daily living (ADLs) such as walking, buttoning clothes, writing, brushing teeth, among others. This condition can even result in a state of vulnerability, with a high risk of falls and other injuries.

Primary Objective and Study Rationale:

Oxaliplatin, widely used to treat patients with colorectal neoplasms, is associated with chemotherapy-induced peripheral neuropathy (CIPN). Given the high prevalence and negative impact of CIPN on quality of life and adherence to cancer treatment, there is a significant gap in identifying effective prevention and management strategies. Although recent evidence suggests that surgical gloves (SG) can mitigate paclitaxel-induced peripheral neuropathy, SGs have not been tested for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). Therefore, the primary objective of this randomized clinical trial is to evaluate whether the use of SGs during treatment can prevent the occurrence of grade 2 or higher OIPN in the hands, as assessed by CTCAE v5.0 and PRO-CTCAE.

Secondary Objective:

To determine the relationship between Body Mass Index and the presence of sarcopenia, with the occurrence of OIPN; To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; To assess symptoms and functional limitations associated with OIPN using the EORTC QLQ-CIPN20 questionnaire.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Virgilio Souza Silva, Medical Doctor, PhD
  • Phone Number: +55 (11) 2189-5000
  • Email: virss2013@gmail.com

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Surgical Gloves
During each chemotherapy cycle, patients in the experimental group will wear compressive surgical gloves (one 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxaliplatin-Induced Peripheral Neuropathy
Time Frame: Baseline, 2 months, 4 months and 6 months
The primary objective of this randomized clinical trial is to evaluate whether the use of surgical gloves during treatment can prevent the occurrence of grade 2 or higher oxaliplatin-induced peripheral neuropathy in the hands, as assessed by CTCAE v5.0 .
Baseline, 2 months, 4 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2).
Time Frame: Baseline, 2 months, 4 months and 6 months
To determine the relationship between BMI and the presence of sarcopenia, with the occurrence of oxaliplatin-induced peripheral neuropathy (OIPN);
Baseline, 2 months, 4 months and 6 months
Health-related Quality of life questionaries
Time Frame: Baseline, 2 months, 4 months and 6 months
To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). For the Functional Scales, higher scores indicate better functioning (0=poorest ; 100=best). For the Symptom Scales, higher scores indicate greater symptom severity (0=no symptoms; 100=severe). For the Global Health Status/Quality of Life Scale, higher scores reflect a better overall perception of health and quality of life (0=poorest; 100=best).
Baseline, 2 months, 4 months and 6 months
Functional limitations associated with OIPN
Time Frame: Baseline, 2 months, 4 months and 6 months
To assess symptoms and functional limitations associated with OIPN using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CIPN20). All scores are transformed into a standardized 0-100 scale, with higher scores indicating severe symptoms.
Baseline, 2 months, 4 months and 6 months
Patient reported Peripheral Neuropathy
Time Frame: Baseline, 2 months, 4 months and 6 months
Patient reported Oxaliplatin-Induced Peripheral Neuropathy assessed by PRO- CTCAE.
Baseline, 2 months, 4 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AC Camargo Cancer Center

Collaborators

Hospital do Cancer de Londrina

Investigators

  • Study Chair: Bruna Catin Kupper, Nurse, PhD, AC Camarco Cancer Center
  • Principal Investigator: Éverton Germano Melo, Medical Doctor, Londrina Cancer Hospital
  • Principal Investigator: Virgilio Souza Silva, Medical Doctor, PhD, AC Camargo Cancer Center
  • Study Chair: Karina Oliveira Ribeiro, Nurse, AC Camargo Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2025

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

September 18, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90669425.4.1001.5432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incidence of grade 2 or higher oxaliplatin-induced peripheral neuropathy (OIPN) in the hands, as assessed by CTCAE v5.0.; Proportion of patients requiring dose adjustments and/or treatment interruptions; Grade 2 or higher OIPN in the patients' feet; Health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; Assessment of symptoms and associated functional limitations due to OIPN using the EORTC QLQ-CIPN20 questionnaire; Evaluation of the correlation between body mass index (BMI) and the presence of sarcopenia, with the occurrence of OIPN.

IPD Sharing Time Frame

Start date: October 2025 End date: September 2026

IPD Sharing Access Criteria

All Principal Investigators and Chairs of this trial

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Cancer

Clinical Trials on Surgical Gloves

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe