Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAC Camargo Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pre-existing neuropathy.
Uncontrolled diabetes.
known glove allergies.
Prior treatment with paclitaxel, docetaxel or oxaliplatin.
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical Gloves
DeviceDuring 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Surgical GlovesExperimental treatment 1 intervention
Group B: No Surgical GlovesNo intervention 0 interventions
Trial outcomes
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 .
Time frame
Baseline, 2 months, 4 months and 6 monthsSecondary outcomes
1
Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2).
To determine the relationship between BMI and the presence of sarcopenia, with the occurrence of oxaliplatin-induced peripheral neuropathy (OIPN);
Time frame
Baseline, 2 months, 4 months and 6 months2
Health-related Quality of life questionaries
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).
Time frame
Baseline, 2 months, 4 months and 6 months3
Functional limitations associated with OIPN
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.
Time frame
Baseline, 2 months, 4 months and 6 months4
Patient reported Peripheral Neuropathy
Patient reported Oxaliplatin-Induced Peripheral Neuropathy assessed by PRO- CTCAE.
Time frame
Baseline, 2 months, 4 months and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
AC Camargo Cancer Center
Lead sponsor
Hospital do Cancer de Londrina
Collaborator
Source ClinicalTrials.gov