Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial.

Sayeh Parkhideh,Maria Tavakoli-Ardakani,Mohadeseh Zeraatkar,Omid Moradi,Abbas Hajifathali,Mahshid Mehdizadeh

doi:10.1007/s00520-021-06409-0

Sayeh Parkhideh, Maria Tavakoli-Ardakani + Show 4 more

Open Access

https://doi.org/10.1007/s00520-021-06409-0

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Abstract

This study aimed to investigate the effects of azithromycin suspension on oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT). 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 by gargling for 30s and swallowing, 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) was considered the main outcome, and the Numerical Rating Scale (NRS:0-10) measured the severity of OM symptoms. In a duration of 15months, 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. 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. Iranian Registry of Clinical Trials: IRCT201603093210N13.

Highlights

Hematopoietic Stem Cell Transplantation (HSCT) is an acceptable cure in many hematologic and autoimmune diseases [1]
In a duration of fifteen months, 88 patients were randomly assigned and 70 patients were evaluable for study outcomes
In total 34 patients diagnosed with Oral Mucositis (OM), the mean time of onset was 6.1±2.2 days and azithromycin was associated with delayed onset (7.5±1.4 vs 5.3±2.2, P = 0.015)

Summary

Introduction

Hematopoietic Stem Cell Transplantation (HSCT) is an acceptable cure in many hematologic and autoimmune diseases [1]. This therapeutic approach involves harvesting, maintaining, and administering stem cells from a donor to the patient after using chemotherapy [2, 3]. Mucositis is a dose-limiting complication of chemotherapy in HSCT patients. Mucosal injury is characterized by inflammation, pain, redness, edema, ulcer and bleeding, and superinfections [6]. This dose-limiting ADR negatively affects the nutritional condition of the patients [7]. In the case of severe thrombocytopenia, oral bleeding may occur in these patients [11]

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