Spots Global Cancer Trial Database for Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
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Trial Identification
Brief Title: Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
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.
Study ID: NCT01087658
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 0001, Greenfield Park, , Canada
Investigational Site Number 124-005, Laval, , Canada
Investigational Site Number 124-007, London, , Canada
Investigational Site Number 124-014, Moncton, , Canada
Investigational Site Number 124-006, Montreal, , Canada
Investigational Site Number 124-004, Montreal, , Canada
Investigational Site Number 124010, Montreal, , Canada
Investigational Site Number 124-011, Montreal, , Canada
Investigational Site Number 124-015, Oshawa, , Canada
Investigational Site Number 124-012, Ottawa, , Canada
Investigational Site Number 124-003, Quebec, , Canada
Investigational Site Number 124-017, Rimouski, , Canada
Investigational Site Number 124-002, Toronto, , Canada
Investigational Site Number 124-016, Winnipeg, , Canada
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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