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Assessment of thyme honey oral gel for the prevention of adriamycin and cyclophosphamide chemotherapy-induced oral mucositis in patients with breast cancer

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Abstract

Purpose

Oral mucositis (OM) is a common complication of cancer treatment that has an impact on a patient’s quality of life and the outcome of cancer therapy. This trial evaluated the effect of thyme honey oral gel for the prevention of chemotherapy-induced OM.

Methods

One hundred ten breast cancer patients who received their first cycle of chemotherapy with adriamycin (60 mg/m2) and cyclophosphamide (600 mg/m2) were randomly recruited into two groups: group A were patients who followed general oral hygiene recommendations and rinsing saline 3 times a day, and group B were patients with similar protocol but supplied with our formulated oral gel to be applied 2 to 4 times a day. Patients were assessed by the World Health Organization (WHO) oral mucositis grading scales and self-assessment daily questionnaire.

Results

The use of thyme honey was associated with diminishing incidence of OM grade ≥ 2 (95% CI, 0.12 to 0.90; P = 0.030), duration of OM (− 3.36 days; 95% CI, − 5.50 to − 1.22; P = 0.037) and delayed occurrence of OM grade ≥ 2 (95% CI, 0.10 to 0.80; P = 0.017).

Conclusion

Thyme honey can be considered as a prophylactic agent for OM and decrease the severity of its symptoms.

Trial registrations

This protocol was registered at the Iranian Registry of Clinical Trials: registration number IRCT201506063106N25, on June 12, 2015; approved by the institutional review board at the Deputy of Research, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran, Iran; and approved by the Ethics Committee of Medical Researches of Pharmaceutical Sciences Branch of Islamic Azad University, Tehran, Iran—reference number 5936, on August 17, 2014.

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Acknowledgements

The author and all the co-authors would like to thank all the nursing staff at the Cancer Institute of Iran for their most level of commitment to patient care and support our research throughout. Most importantly, we would like to express our great appreciation to all the patients who participated in this study. We believe their high inspiration and commitment had a major role in the completion of our study.

Author contributions

Sanambar Sadighi is a consultant oncologist who was responsible for overall patient care and all dealings with our patients. She has reviewed the manuscript throughout the process of writing.

Soheila Manifar is a consultant oral and maxillofacial dentist who was responsible for the oral assessment of our cancer patients during our investigation and post-treatment for routine assessment. She has reviewed the manuscript throughout the process.

Hooman Bakhshandeh is an associate professor of epidemiology who was responsible for the assessment of the design of our investigation and was involved in the randomization of our patients. He was responsible for data analysis and all statistical considerations in our investigation.

Elnaz Jahanbani Mazraeh is a clinical pharmacist. She was in charge of all co ordinations and patient recruitment. She was directly involved with day-to-day activities under the supervision of all supervisors. She was involved in data gathering and manuscript writing. She is the first author of this investigation.

Mehdi Rajabi is a senior clinical lecturer and researcher. He was responsible for the design of the study and overseeing the investigation. He was involved in manuscript editing and the corresponding author for this investigation.

Funding

The authors did not receive support from any organization for the submitted work.

Author information

Authors and Affiliations

  1. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, P.O. Box 19419, Yasaman St., Yakhchal Ave., Qolhak Ave., Shariati Ave, Tehran, Iran

    Elnaz Jahanbani Mazraeh & Mehdi Rajabi

  2. Department of Hematology/Oncology, Cancer Institute of Iran, Imam Khomeini Medical Center, Tehran University of Medical Sciences, Tehran, Iran

    Sanambar Sadighi

  3. Department of Oral and Maxillofacial Medicine, School of Dentistry, Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Tehran, Iran

    Soheila Manifar

  4. Department of Epidemiology, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran

    Hooman Bakhshandeh

  5. Department of Clinical Pharmacy, University Hospitals of North Midlands NHS Trust, Stoke-On-Trent, ST4 6QG, UK

    Mehdi Rajabi

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  1. Elnaz Jahanbani Mazraeh
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Contributions

S.S is a consultant oncologist who was responsible for overall patient care and all dealing with our patients. She has reviewed the manuscript throughout the process of writing. S.M is a consultant oral & maxillofacial dentist who was responsible for oral assessment of our cancer patients during our investigation and post treatment for routine assessment. She has reviewed the manuscript throughout the process. H.B is an associate professor of epidemiology who was responsible for the assessment of the design of our investigation and involved in randomization of our patients. He was responsible for data analysis and all statistical considerations in our investigation. E.J is a clinical pharmacist. She was in charge of all co ordinations and patient recruitment. She was directly involved with day to day activities under supervision of all supervisors. She was involved in data gathering and manuscript writing. She is the first author on this investigation. M.R is a senior clinical lecturer and researcher. He was responsible for the design of the study and overseeing the investigation. He was involved in manuscript editing and corresponding author for this investigation.

Corresponding author

Correspondence to Mehdi Rajabi.

Ethics declarations

Ethics approval

Approval was obtained from the ethics committee of Medical Researches of Pharmaceutical Sciences Branch of Islamic Azad University, Tehran, Iran.—Reference number 5936, on August 17, 2014. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Conflict of interests

The authors declare no competing interests.

Disclaimer

The authors would declare that there is no conflict of interest in any context associated with this manuscript. The data presented here are not presented as oral or written in any scientific arena.

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Name of Institution at which the work was performed: Department of Hematology/Oncology, Cancer Institute of Iran, Imam Khomeini Medical Center, Tehran University of Medical Sciences, Tehran, Iran.

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Jahanbani Mazraeh, E., Sadighi, S., Manifar, S. et al. Assessment of thyme honey oral gel for the prevention of adriamycin and cyclophosphamide chemotherapy-induced oral mucositis in patients with breast cancer. Support Care Cancer 31, 497 (2023). https://doi.org/10.1007/s00520-023-07943-9

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