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Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity

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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Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

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A Multicenter, Open-Label, Phase II Study for the Recombinant Human Interleukin-1 Receptor Antagonist for Injection in Combination of FOLFIRI in Patients with Recurrent Metastatic Colorectal Cancer

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