Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
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.