Abstract
Objectives: This study aimed to investigate the effects of Azithromycin suspension on oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT)Methods and material: The study was designed as a single-blind randomized controlled trial in Taleghani medical center affiliated to Shahid Beheshti University of Medical Sciences Tehran Iran. Patients undergoing HSCT were randomly assigned to intervention or control groups. Azithromycin suspension was administered twice daily for gargling for 30 seconds and swallow, on the first day of chemotherapy for patients in the intervention group. Graded Oral Mucositis (OM) occurrence based on National Cancer Institute Common Toxicity Criteria (NCI-CTC) scale (grade 0 to 5) considered as the main outcome and the Numerical Rating Scale (NRS:0-10) measured the severity of OM symptoms.Results: In a duration of fifteen months, 88 patients were randomly assigned and finally 70 patients were evaluable for study outcomes (randomized 1:1 to azithromycin versus no-azithromycin). The incidence and duration of the mucositis significantly improved in the intervention group compared to the control. Azithromycin use was consistent with a lower rate of dryness (P<0.001), dysphagia (P<0.001), and loss of sense of taste (P<0.001). Also, in the intervention group, lower intensity of pain due to mucositis (P=0.01) and lower duration of mucositis were observed (p=0.045). No significant adverse drug reaction was observed in patients receiving azithromycin. Conclusion: Based on the result from this study Azithromycin suspension is an effective option in the prevention and treatment of chemotherapy-induced OM. Further study is needed to assess the effect of azithromycin and comparison with other therapeutic options.
Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial
