Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
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ABSTRACT: Primary Objective:
To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred.
Secondary Objective:
To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN.
To determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4.
To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale.
To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients.
DISEASE(S): Neurotoxicity Syndromes,Colorectal Neoplasms
PROVIDER: 2086375 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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