Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
NCT ID: NCT07285356
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-10-06
2026-09-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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 Surgical Gloves
The control arm will receive treatment according to current recommendations without the use of any devices on the hands.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Uncontrolled diabetes.
* known glove allergies.
* Prior treatment with paclitaxel, docetaxel or oxaliplatin.
18 Years
ALL
No
Sponsors
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Hospital do Cancer de Londrina
UNKNOWN
AC Camargo Cancer Center
OTHER
Responsible Party
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Virgilio Souza e Silva
Doctor and Head Oncologist of the Clinical Oncology Department at AC Camargo Cancer Center
Principal Investigators
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Bruna Catin Kupper, Nurse, PhD
Role: STUDY_CHAIR
AC Camarco Cancer Center
Éverton Germano Melo, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Londrina Cancer Hospital
Virgilio Souza Silva, Medical Doctor, PhD
Role: PRINCIPAL_INVESTIGATOR
AC Camargo Cancer Center
Karina Oliveira Ribeiro, Nurse
Role: STUDY_CHAIR
AC Camargo Cancer Center
Locations
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A.C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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90669425.4.1001.5432
Identifier Type: -
Identifier Source: org_study_id