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

Summary

RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.

Timeline

Start

2010-06

Primary completion

2012-12

Completion

2013-03

Outcome

Missed primary endpoint

registry analysis (unspecified test); Calcium Gluconate + Magnesium Sulfate (Pre and Post) vs Placebo (Pre and Post); p = .73; Wilcoxon (Mann-Whitney) NCT01099449 ↗

paper There were no statistically significant neuropathy differences among the study arms as measured by the primary end point PMID 24297951 ↗

Publications

• Hertz DL, Dockter TJ, Satele DV, Loprinzi CL, Le-Rademacher J. Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912). Support Care Cancer. 2021 Dec;29(12):7855-7863. doi: 10.1007/s00520-021-06371-x. Epub 2021 Jun 27.
• Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, Seisler D, Qamar R, Lewis GC, Grothey A. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol. 2014 Apr 1;32(10):997-1005. doi: 10.1200/JCO.2013.52.0536. Epub 2013 Dec 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Magnesium Sulfate	Other / unclassified	—	Intravenous
Subject	calcium gluconate	Small molecule	—	Intravenous
Background	Oxaliplatin	Small molecule	—	Intravenous

Indications