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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 200
- Locations
- 14
- Primary Endpoint
- Occurence of peripheral sensory neuropathy (PSN) grade 2, 3 and 4 assessed by the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Glutamine and calcium magnesium
Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.
All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.
Intervention: Glutamine (Drug)
Glutamine and calcium magnesium
Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.
All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.
Intervention: Calcium and Magnesium (Drug)
Calcium magnesium
1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.
All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.
Intervention: Calcium and Magnesium (Drug)
Outcomes
Primary Outcomes
Occurence of peripheral sensory neuropathy (PSN) grade 2, 3 and 4 assessed by the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE)
Time Frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Secondary Outcomes
- Dose-reduction, dose-delay and discontinuation of oxaliplatin due to PSN grade 3 or 4(Every cycle i.e. 2 or 3 weeks according to the treatment arm)
- Patient self-reported neurotoxicity scale for chronic peripheral neuropathy(Every cycle i.e. 2 or 3 weeks according to the treatment arm)
- Cumulative dose of oxaliplatin and time of onset when the first PSN grade 2, 3 or 4 occurs(Every cycle i.e. 2 or 3 weeks according to the treatment arm)
- Progression Free Survival / PFS (for metastatic patients)(Every cycle i.e. 2 or 3 weeks according to the treatment arm)