Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy

NCT07285356 | Recruiting DMC

• 1 other identifier: 90669425.4.1001.5432
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Oxaliplatin-induced Peripheral Neuropathy

Keywords

oxaliplatin-induced peripheral neuropathy; Peripheral Neuropathy; Oxaliplatin; Surgical Gloves; Body Mass Index (BMI); Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Oxaliplatin-Induced Peripheral Neuropathy

  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 Outcomes (4)

• Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2).

  Baseline, 2 months, 4 months and 6 months

• Health-related Quality of life questionaries

  Baseline, 2 months, 4 months and 6 months

• Functional limitations associated with OIPN

  Baseline, 2 months, 4 months and 6 months

• Patient reported Peripheral Neuropathy

  Baseline, 2 months, 4 months and 6 months

Study Arms (2)

Surgical Gloves

EXPERIMENTAL

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

No Surgical Gloves

NO INTERVENTION

The control arm will receive treatment according to current recommendations without the use of any devices on the hands.

Interventions

Surgical Gloves DEVICE

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.

Surgical Gloves

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Pre-existing neuropathy.
• Uncontrolled diabetes.
• known glove allergies.
• Prior treatment with paclitaxel, docetaxel or oxaliplatin.

Sponsors & Collaborators

• AC Camargo Cancer Center: lead
• Hospital do Cancer de Londrina: collaborator

Study Sites (1)

A.C. Camargo Cancer Center

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (4)

• Smith EM. Current methods for the assessment and management of taxane-related neuropathy. Clin J Oncol Nurs. 2013 Feb;17 Suppl:22-34. doi: 10.1188/13.CJON.S1.22-34.

  PMID: 23360700 BACKGROUND

• Soveri LM, Lamminmaki A, Hanninen UA, Karhunen M, Bono P, Osterlund P. Long-term neuropathy and quality of life in colorectal cancer patients treated with oxaliplatin containing adjuvant chemotherapy. Acta Oncol. 2019 Apr;58(4):398-406. doi: 10.1080/0284186X.2018.1556804. Epub 2019 Jan 14.

  PMID: 30638100 BACKGROUND

• Tofthagen C. Patient perceptions associated with chemotherapy-induced peripheral neuropathy. Clin J Oncol Nurs. 2010 Jun;14(3):E22-8. doi: 10.1188/10.CJON.E22-E28.

  PMID: 20529785 BACKGROUND

• Wang S, Zheng R, Li J, Zeng H, Li L, Chen R, Sun K, Han B, Bray F, Wei W, He J. Global, regional, and national lifetime risks of developing and dying from gastrointestinal cancers in 185 countries: a population-based systematic analysis of GLOBOCAN. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):229-237. doi: 10.1016/S2468-1253(23)00366-7. Epub 2024 Jan 4.

  PMID: 38185129 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Peripheral Nervous System Diseases; Sarcopenia

Interventions

Gloves, Surgical

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gloves, Protective; Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Surgical Attire; Surgical Equipment; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Bruna Catin Kupper, Nurse, PhD

  AC Camarco Cancer Center

  STUDY CHAIR

• Éverton Germano Melo, Medical Doctor

  Londrina Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Virgilio Souza Silva, Medical Doctor, PhD

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

• Karina Oliveira Ribeiro, Nurse

  AC Camargo Cancer Center

  STUDY CHAIR

Central Study Contacts

Virgilio Souza Silva, Medical Doctor, PhD

CONTACT

+55 (11) 2189-5000; virss2013@gmail.com

Éverton Germano Melo, Medical Doctor

CONTACT

+55 (43) 3379-2600; evertongermanomelo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor and Head Oncologist of the Clinical Oncology Department at AC Camargo Cancer Center

Model Details: This study is a prospective, open-label, randomized, controlled, multicenter clinical trial.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 16, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start date: October 2025 End date: September 2026
• Access Criteria: All Principal Investigators and Chairs of this trial

Locations

BR (1)