Background: Nausea and vomiting are the common side-effects of chemotherapy in children with malignancy. In this study, the effectiveness of vitamin B6 in reducing the chemo-induced nausea and vomiting (CINV) in children was tested. Material and methods: A triple-blind clinical trials was performed on 100 children with malignancy referring to the pediatric clinic of Amir Kabir Hospital, Arak, Iran. Besides the infusion of granisetron (3mg/3ml) half an hour before each chemotherapy cycle, an intravenous dose of vitamin B6 (100 mg for children from 2 to 5 years old, 200 mg for children from 5 to 10 years old, and 300 mg for children older than 10) was given 6 hours before the first chemotherapy cycle and placebo was injected (2-5 years old: 100 mg, 5-10 years old: 200 mg, age≥ 10 years old: 300mg) 6 hours before the second cycle. Then the severity of nausea and the frequency of vomiting episodes in each cycle were recorded to be compared. Results: The mean age of children was 7.98 ± 3.133 years old. The most common and rare malignancy were acute lymphocytic leukemia (ALL) (46%) and ependymoma (0.5%), respectively. Vincristin was the most commonly used chemotherapy agent (28%). A positive correlation between the severity of nausea(R=0.313, P-value=0.0016) and frequency of vomiting with age was found (R=0.319, P-value=0.0012). However, no noticeable association was observed between N/V and gender (P-value.0.05). There was a considerable correlation between the frequency of vomiting and different tumor types in this study (P-value=0.0006).In comparison with placebo, Vitamin B6 significantly reduced the severity of nausea (P = 0.0001) as well as the frequency of vomiting (P-value = 0.0005). It was also more effective in ALL compared to rhabdomyosarcoma (P-value=0.001). Conclusion: This study suggested that vitamin B6 can be considered as an appropriate alternative to treat CINV in children with malignancy.
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