Colorectal Neoplasms Clinical Trial
Official title:
A Multicentre, Randomized, Open-label, Phase III Study Comparing the Efficacy of Oral Glutamine and Calcium-magnesium With Calcium-magnesium Alone in the Prevention of Oxaliplatin-induced Neurotoxicity in Patients With Colorectal Cancer Treated With Oxaliplatin in Adjuvant or 1st Line Metastatic Settings.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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