Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT07285356
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005932', 'term': 'Gloves, Surgical'}], 'ancestors': [{'id': 'D017575', 'term': 'Gloves, Protective'}, {'id': 'D011481', 'term': 'Protective Clothing'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D003020', 'term': 'Clothing'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a prospective, open-label, randomized, controlled, multicenter clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxaliplatin-Induced Peripheral Neuropathy', 'timeFrame': 'Baseline, 2 months, 4 months and 6 months', 'description': '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 .'}], 'secondaryOutcomes': [{'measure': 'Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2).', 'timeFrame': 'Baseline, 2 months, 4 months and 6 months', 'description': 'To determine the relationship between BMI and the presence of sarcopenia, with the occurrence of oxaliplatin-induced peripheral neuropathy (OIPN);'}, {'measure': 'Health-related Quality of life questionaries', 'timeFrame': 'Baseline, 2 months, 4 months and 6 months', 'description': "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)."}, {'measure': 'Functional limitations associated with OIPN', 'timeFrame': 'Baseline, 2 months, 4 months and 6 months', 'description': '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.'}, {'measure': 'Patient reported Peripheral Neuropathy', 'timeFrame': 'Baseline, 2 months, 4 months and 6 months', 'description': 'Patient reported Oxaliplatin-Induced Peripheral Neuropathy assessed by PRO- CTCAE.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxaliplatin-induced peripheral neuropathy', 'Peripheral Neuropathy', 'Oxaliplatin', 'Surgical Gloves', 'Body Mass Index (BMI)', 'Sarcopenia'], 'conditions': ['Colon Cancer', 'Oxaliplatin-induced Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '23360700', 'type': 'BACKGROUND', 'citation': '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': '30638100', 'type': 'BACKGROUND', 'citation': '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': '20529785', 'type': 'BACKGROUND', 'citation': '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': '38185129', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPrimary Objective and Study Rationale:\n\nOxaliplatin, 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.\n\nSecondary Objective:\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older who have provided written informed consent.\n* Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV.\n* Oxaliplatin-based treatment in the context of localized or metastatic disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n* Pre-existing neuropathy.\n* Uncontrolled diabetes.\n* known glove allergies.\n* Prior treatment with paclitaxel, docetaxel or oxaliplatin.'}, 'identificationModule': {'nctId': 'NCT07285356', 'acronym': 'GLOX-PEN', 'briefTitle': 'Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'AC Camargo Cancer Center'}, 'officialTitle': 'GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy', 'orgStudyIdInfo': {'id': '90669425.4.1001.5432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical Gloves', 'description': '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.', 'interventionNames': ['Device: Surgical Gloves']}, {'type': 'NO_INTERVENTION', 'label': 'No Surgical Gloves', 'description': 'The control arm will receive treatment according to current recommendations without the use of any devices on the hands.'}], 'interventions': [{'name': 'Surgical Gloves', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Surgical Gloves']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Bruna Kupper', 'role': 'CONTACT', 'email': 'bruna.catin@accamargo.org.br', 'phone': '+551121895010', 'phoneExt': '2832'}], 'facility': 'A.C. Camargo Cancer Center', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Virgilio Souza Silva, Medical Doctor, PhD', 'role': 'CONTACT', 'email': 'virss2013@gmail.com', 'phone': '+55 (11) 2189-5000'}, {'name': 'Éverton Germano Melo, Medical Doctor', 'role': 'CONTACT', 'email': 'evertongermanomelo@gmail.com', 'phone': '+55 (43) 3379-2600'}], 'overallOfficials': [{'name': 'Bruna Catin Kupper, Nurse, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'AC Camarco Cancer Center'}, {'name': 'Éverton Germano Melo, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Londrina Cancer Hospital'}, {'name': 'Virgilio Souza Silva, Medical Doctor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AC Camargo Cancer Center'}, {'name': 'Karina Oliveira Ribeiro, Nurse', 'role': 'STUDY_CHAIR', 'affiliation': 'AC Camargo Cancer Center'}]}, 'ipdSharingStatementModule': {'url': 'https://accamargo.org.br/pacientes/estudos-clinicos/lista-de-estudos-clinicos', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Start date: October 2025 End date: September 2026', 'ipdSharing': 'YES', '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.", 'accessCriteria': 'All Principal Investigators and Chairs of this trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AC Camargo Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital do Cancer de Londrina', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor and Head Oncologist of the Clinical Oncology Department at AC Camargo Cancer Center', 'investigatorFullName': 'Virgilio Souza e Silva', 'investigatorAffiliation': 'AC Camargo Cancer Center'}}}}