Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .
Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).
PURPOSE Cumulative neurotoxicity is a prominent toxicity of oxaliplatin-based therapy . Intravenous calcium and magnesium have been extensively used to reduce oxaliplatin-induced neurotoxicity . This trial was design ed to definitively test whether calcium/magnesium decreases oxaliplatin-related neurotoxicity . PATIENTS AND METHODS In all , 353 patients with colon cancer undergoing adjuvant therapy with FOLFOX ( fluorouracil , leucovorin , and oxaliplatin )  were r and omly assigned to intravenous calcium/magnesium before and after oxaliplatin , a placebo before and after , or calcium/magnesium before and placebo after . The primary end point was cumulative neurotoxicity measured by the sensory scale of the European Organisation for Research and Treatment of Cancer Quality of Life Question naire-Chemotherapy-Induced Peripheral Neuropathy 20 tool . RESULTS There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy , including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale . In addition , calcium/magnesium did not substantially decrease oxaliplatin-induced acute neuropathy . CONCLUSION This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .