Gamelin, L., Boisdron-Celle, M., Delva, R., Geurin-Meyer, V., Ifrah, N., Morel, A., & Gamelin, E. (2004). Prevention of oxaliplatin-related neurotoxicity by calcium and magnesium infusions: A retrospective study of 161 patients receiving oxaliplatin combined with 5-fluourouracil and leucovorin for advanced colorectal cancer. Clinical Cancer Research, 10(12, pt. 1), 4055–4061.

Participants in the treatment group received infusions of calcium gluconate and magnesium sulfate (1 g) before and after oxaliplatin. The chemotherapy protocol consisted of combination oxaliplatin, 5-fluourouracil (5-FU), and leucovorin. Three regimens of oxaliplatin were used: 85 mg/m² every two weeks, 100 mg/m² every two weeks, or 130 mg/m² every three weeks.

A total of 161 patients were enrolled in the study, with 96 placed in the treatment group and 65 in the control group.

The study had a retrospective design.

Toxicity was graded every one to two weeks by staff according to the National Cancer Institute's Common Terminology Criteria for Adverse Events and an oxaliplatin-specific neurotoxicity scale that assessed paresthesias.

Paresthesias, trismus, cramps, limb pain, and diarrhea were significantly less frequent in the treatment group. Pharyngolaryngeal dysesthesia were never reported in the treatment group versus 9% in the control group. In addition, less grade 3 toxicity was reported in the treatment group compared to the control group. At the end of oxaliplatin therapy, 65% of participants in the treatment group had no evidence of chemotherapy-induced peripheral neuropathy (CIPN) compared to 37% in the control group. By the end of treatment, 20% of patients in the treatment group showed evidence of CIPN versus 45% in the control group. Patients with grade 2 or 3 neurotoxicity at the end of treatment with oxaliplatin (85 mg/m²) recovered more rapidly from CIPN than those in the control group.

• The study was retrospective and not randomized or blinded.
• Staff who performed the assessments may have been biased in reporting.
• More patients who received either FOLFOX 4 or FOLFOX 6 regimens were included in the treatment group, making results more open to bias and placebo effect.