RecruitingRecruiting
Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
NCT07285356 · AC Camargo Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
About this study
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.
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.
Study design
Enrollment target: 84 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-06
Estimated completion: 2026-09-18
Last updated: 2025-12-16
Interventions
Device: Surgical Gloves
Primary outcomes
- • Oxaliplatin-Induced Peripheral Neuropathy (Baseline, 2 months, 4 months and 6 months)
Sponsor
AC Camargo Cancer Center · other
With: Hospital do Cancer de Londrina
Contacts & investigators
ContactVirgilio Souza Silva, Medical Doctor, PhD · contact · virss2013@gmail.com · +55 (11) 2189-5000
ContactÉverton Germano Melo, Medical Doctor · contact · evertongermanomelo@gmail.com · +55 (43) 3379-2600
InvestigatorBruna Catin Kupper, Nurse, PhD · study_chair, AC Camarco Cancer Center
InvestigatorÉverton Germano Melo, Medical Doctor · principal_investigator, Londrina Cancer Hospital
InvestigatorVirgilio Souza Silva, Medical Doctor, PhD · principal_investigator, AC Camargo Cancer Center
All locations (1)
A.C. Camargo Cancer CenterRecruiting
São Paulo, São Paulo, Brazil