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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.
1Research sites
84Patients around the world