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

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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 by gargling for 30 s 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.

Results

In a duration of 15 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.

Trial registration

Iranian Registry of Clinical Trials: IRCT201603093210N13

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Data availability

The data that support the findings of this study are available on request from the corresponding author (MTA).

Code availability

N/A

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Funding

The study was conducted under the supervision of deputy of research and technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran, and did not receive any extra source of financial support from secondary institution or company.

Author information

Authors and Affiliations

  1. Hematopoietic Stem Cell Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Sayeh Parkhideh, Abbas Hajifathali, Mahshid Mehdizadeh & Maria Tavakoli-Ardakani

  2. Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valiasr St, 1991953381, Tehran, Iran

    Mohadeseh Zeraatkar, Omid Moradi & Maria Tavakoli-Ardakani

  3. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Mahshid Mehdizadeh

Authors
  1. Sayeh Parkhideh
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  2. Mohadeseh Zeraatkar
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  3. Omid Moradi
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  4. Abbas Hajifathali
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  5. Mahshid Mehdizadeh
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  6. Maria Tavakoli-Ardakani
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Contributions

SP, acquisition of data, critical revision of the manuscript for important intellectual content, study supervision; MZ, acquisition of data, drafting of the manuscript, technical support; OM, drafting of the manuscript, statistical analysis, critical revision of the manuscript for important intellectual content; AH, acquisition of data, critical revision of the manuscript for important intellectual content, study supervision; MM, acquisition of data, critical revision of the manuscript for important intellectual content, study supervision; MTA, study concept and design, acquisition of data, drafting of the manuscript, statistical analysis, administrative and material support, critical revision of the manuscript for important intellectual content, study supervision.

Corresponding author

Correspondence to Maria Tavakoli-Ardakani.

Ethics declarations

Ethics approval

The study was approved by the board of ethics committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran (Code: IR.SBMU.PHNM.1394.307).

Consent to participate

The written informed consent was obtained from all patients prior to enrollment.

Consent for publication

The consent for publication of the result of the study was obtained from all of the participants. No personal/contact information of the participant was reported in this study.

Competing interests

The authors declare no competing interests.

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Parkhideh, S., Zeraatkar, M., Moradi, O. et al. Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial . Support Care Cancer 30, 251–257 (2022). https://doi.org/10.1007/s00520-021-06409-0

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

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