Abstract
Purpose
Considering the complex pathobiology of oral mucositis, especially in oral cancer patients, the prevention and treatment of oral mucositis in patients undergoing radiotherapy remains an essential and clinically crucial unmet need. The present study aims to investigate and compare the effects of synbiotic mouthwash with normal saline mouthwash on the prevention and control of radiotherapy-induced oral mucositis in oral cancer patients.
Methods
Double-blind, randomized clinical trial (RCT) performed on 64 oral cancer patients who underwent radiotherapy (IRCT20201106049288N1, registration date: 2020–12-23). Patients were divided randomly into the case (32 subjects) and control (32 subjects) groups. All patients underwent intensity-modulated radiotherapy and received 6000 cGY of radiotherapy in 34 fractions. All patients received the usual treatment for mucositis, but in the case group, synbiotic mouthwash was prescribed and in the control group, normal saline mouthwash was prescribed from a day before the start to the end of radiotherapy treatment. Patients were monitored every session for 6 weeks to check the progression, oral involvement severity, and mucositis grade.
Results
The case group showed a significant reduction in the oral mucositis severity. The mucositis grade in the case group from the 7th session of oral examination was significantly lower than the control (p < 0.05), and this significant difference persisted until the last session of oral examination. Incidence rates of severe oral mucositis (grade 3) during the treatment period were 11.59% in the case and 36.45% in control (p < 0.001).
Conclusion
Synbiotic mouthwash significantly reduces and prevents oral mucositis intensity in oral cancer patients undergoing radiotherapy.
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Data availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Abbreviations
- AJCC:
-
American Joint Committee on Cancer
- IMRT:
-
Intensity-modulated radiotherapy
- GRAS:
-
Generally recognized as safe
- LPS:
-
Lipopolysaccharide
- OE:
-
Oral examination
- OM:
-
Oral mucositis
- OSCC:
-
Oral squamous cell carcinoma
- p :
-
P-Value
- RCT:
-
Randomized clinical trial
- TLR2:
-
Toll-like receptor 2
- TLRs:
-
Toll-like receptors
- WHO:
-
World Health Organization
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MK and SM conceived the study idea and led data collection. MK, ZM, and SM created the study protocol and wrote the original draft. MK, ZM and SK contributed to data analysis/interpretation and preparation of the manuscript. MK, SM, and ZM led the writing—review and editing. MK, ZM, and SK interpreted the results. All authors read and approved the final manuscript.
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Before starting radiotherapy, the purpose of the study and its steps were explained in both case and control groups. After obtaining the patient’s informed consent in accordance with the ethics committee requirements at the psarticipating institutes and the Declaration of Helsinki, the study was started. This study was approved by the Tehran University of Medical Sciences Ethical Committee (Ethical code: IR.TUMS.DENTISTRY.REC.1399.176), and this study was registered in the Clinical Trial Registration Center of Iran (IRCT code: IRCT20201106049288N1). All methods were performed under the relevant guidelines and regulations, and this study was conducted in accordance with the Declaration of Helsinki [31].
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The authors declare no competing interests.
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Manifar, S., Koopaie, M., Jahromi, Z.M. et al. Effect of synbiotic mouthwash on oral mucositis induced by radiotherapy in oral cancer patients: a double-blind randomized clinical trial. Support Care Cancer 31, 31 (2023). https://doi.org/10.1007/s00520-022-07521-5
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DOI: https://doi.org/10.1007/s00520-022-07521-5