A Pilot Study of Investigating the Effects of Glutamine and Vincristine-induced Neuropathy in Pediatric Patients with Cancer
Patients with cancer are amongst the highest users of complementary/alternative therapies. Recent surveys have found 84% of pediatric oncology patients on standard anticancer protocols are taking some form of complementary/alternative medicine. However the safety of these therapies combined with chemotherapy is unknown. Today more than 70% of children diagnosed with cancer are long-term survivors of their disease. Despite the increase in survival, at least 60-70% of patients will have at least one disability as a result of their cancer therapy. Efforts to avoid long-term toxicity may necessitate a reduction of chemotherapy or delays in their treatment protocols. This deviation from recommended optimal therapy can decrease efficacy and increase a child’s risk of relapse. Thus, innovative adjunctive therapies that enable optimal doses of cancer therapy to be administered without compromising the efficacy of the anticancer agents and mitigate the toxicity associated with certain cancer therapy regimens are of increasing interest to the clinician. The nutritional supplement, glutamine, is classified as an alternative medicine in that it is currently not an established supportive care agent in use with conventional chemotherapy protocols. Preliminary laboratory and human data has suggested that glutamine may have a promising role as a prophylaxis against VCR-induced neuropathy. We are proposing to conduct a double-blind, placebo controlled randomized trial to determine the efficacy of glutamine supplementation in children encountering neurotoxicity due to vincristine-containing chemotherapy regimens. Patients will be randomized to receive either a placebo (inactive substance) or the active supplement, glutamine. Patients will take the supplement for a one-month period. Measures of neuropathy will be assessed throughout the study at their routine visits. Patients will also be routinely monitored for any adverse effects. Our hypothesis is that glutamine supplementation in pediatric patients with cancer encountering dose reductions or delays in therapy due to neuropathy from vincristine-containing chemotherapy regimens will benefit and allow the patient to withstand their recommended chemotherapy schedule.