Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial
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...
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| Veröffentlicht in: | Supportive care in cancer 2022, Vol.30 (1), p.251-257 |
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| creator | Parkhideh, Sayeh Zeraatkar, Mohadeseh Moradi, Omid Hajifathali, Abbas Mehdizadeh, Mahshid Tavakoli-Ardakani, Maria |
| description | 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 |
| doi_str_mv | 10.1007/s00520-021-06409-0 |
| format | Article |
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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</description><identifier>ISSN: 0941-4355</identifier><identifier>EISSN: 1433-7339</identifier><identifier>DOI: 10.1007/s00520-021-06409-0</identifier><identifier>PMID: 34259920</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Analysis ; Antibiotics ; Azithromycin ; Azithromycin - adverse effects ; Cancer ; Chemotherapy ; Clinical trials ; Disease management ; Disease prevention ; Drug therapy ; Health aspects ; Hematopoietic Stem Cell Transplantation - adverse effects ; Hematopoietic stem cells ; Humans ; Iran ; Medical centers ; Medicine ; Medicine & Public Health ; Mucositis ; Nursing ; Nursing Research ; Oncology ; Oral medication ; Original Article ; Pain Medicine ; Rehabilitation Medicine ; Single-Blind Method ; Stem cell research ; Stem cell transplantation ; Stem cells ; Stomatitis ; Stomatitis - chemically induced ; Stomatitis - drug therapy ; Stomatitis - prevention & control ; Taste ; Transplantation</subject><ispartof>Supportive care in cancer, 2022, Vol.30 (1), p.251-257</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021</rights><rights>2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.</rights><rights>COPYRIGHT 2022 Springer</rights><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c486t-be9a7cfc03fa6b7263121e60ffd903b1195bdb4ef13d62839ced785388f8968d3</citedby><cites>FETCH-LOGICAL-c486t-be9a7cfc03fa6b7263121e60ffd903b1195bdb4ef13d62839ced785388f8968d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00520-021-06409-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00520-021-06409-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,778,782,27911,27912,41475,42544,51306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34259920$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Parkhideh, Sayeh</creatorcontrib><creatorcontrib>Zeraatkar, Mohadeseh</creatorcontrib><creatorcontrib>Moradi, Omid</creatorcontrib><creatorcontrib>Hajifathali, Abbas</creatorcontrib><creatorcontrib>Mehdizadeh, Mahshid</creatorcontrib><creatorcontrib>Tavakoli-Ardakani, Maria</creatorcontrib><title>Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial</title><title>Supportive care in cancer</title><addtitle>Support Care Cancer</addtitle><addtitle>Support Care Cancer</addtitle><description>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</description><subject>Analysis</subject><subject>Antibiotics</subject><subject>Azithromycin</subject><subject>Azithromycin - adverse effects</subject><subject>Cancer</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Disease management</subject><subject>Disease prevention</subject><subject>Drug therapy</subject><subject>Health aspects</subject><subject>Hematopoietic Stem Cell Transplantation - adverse effects</subject><subject>Hematopoietic stem cells</subject><subject>Humans</subject><subject>Iran</subject><subject>Medical centers</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mucositis</subject><subject>Nursing</subject><subject>Nursing Research</subject><subject>Oncology</subject><subject>Oral medication</subject><subject>Original Article</subject><subject>Pain Medicine</subject><subject>Rehabilitation Medicine</subject><subject>Single-Blind Method</subject><subject>Stem cell research</subject><subject>Stem cell transplantation</subject><subject>Stem cells</subject><subject>Stomatitis</subject><subject>Stomatitis - chemically induced</subject><subject>Stomatitis - drug therapy</subject><subject>Stomatitis - prevention & control</subject><subject>Taste</subject><subject>Transplantation</subject><issn>0941-4355</issn><issn>1433-7339</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kk1vFSEUhidGY6_VP-DCkLhxM5WPYWZwd9P4lTRxo2vCwOGWZoARGJP2H_VfyvRWG40xLIDD8745h7xN85LgM4Lx8DZjzCluMSUt7jssWvyo2ZGOsXZgTDxudlh0pO0Y5yfNs5yvMCbDwOnT5oR1lAtB8a653d-4cpmiv9YuoJjUjPKaFwjZxYBqaUnwA0LZbioY5FVQB_C1gqI98n7VMbvi8h2uiquPGa3BQDpEFw7oErwqcYkOitMoF_BIwzyjklTIy6xCUZv_O6RQrZjo3Q0YpGMoKc5zPZbk1Py8eWLVnOHF_X7afPvw_uv5p_biy8fP5_uLVndjX9oJhBq01ZhZ1U8D7RmhBHpsrRGYTYQIPpmpA0uY6enIhAYzjJyNox1FPxp22rw5-i4pfl8hF-ld3vpVAeKaJeWc8EH0mFX09V_oVVxTqN1J2uNOjHwk4oE6qBmkCzbWwfVmKvf92HHeDeNQqbN_UHUZ8K7-BVhX638I6FGgU8w5gZVLcl6la0mw3PIhj_mQNR_yLh8SV9Gr-47XyYP5LfkViAqwI5DrUzhAehjpP7Y_Ad6DyRc</recordid><startdate>2022</startdate><enddate>2022</enddate><creator>Parkhideh, Sayeh</creator><creator>Zeraatkar, Mohadeseh</creator><creator>Moradi, Omid</creator><creator>Hajifathali, Abbas</creator><creator>Mehdizadeh, Mahshid</creator><creator>Tavakoli-Ardakani, Maria</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88J</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HEHIP</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2R</scope><scope>M2S</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>2022</creationdate><title>Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial</title><author>Parkhideh, Sayeh ; Zeraatkar, Mohadeseh ; Moradi, Omid ; Hajifathali, Abbas ; Mehdizadeh, Mahshid ; Tavakoli-Ardakani, Maria</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c486t-be9a7cfc03fa6b7263121e60ffd903b1195bdb4ef13d62839ced785388f8968d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Analysis</topic><topic>Antibiotics</topic><topic>Azithromycin</topic><topic>Azithromycin - adverse effects</topic><topic>Cancer</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Disease management</topic><topic>Disease prevention</topic><topic>Drug therapy</topic><topic>Health aspects</topic><topic>Hematopoietic Stem Cell Transplantation - adverse effects</topic><topic>Hematopoietic stem cells</topic><topic>Humans</topic><topic>Iran</topic><topic>Medical centers</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mucositis</topic><topic>Nursing</topic><topic>Nursing Research</topic><topic>Oncology</topic><topic>Oral medication</topic><topic>Original Article</topic><topic>Pain Medicine</topic><topic>Rehabilitation Medicine</topic><topic>Single-Blind Method</topic><topic>Stem cell research</topic><topic>Stem cell transplantation</topic><topic>Stem cells</topic><topic>Stomatitis</topic><topic>Stomatitis - chemically induced</topic><topic>Stomatitis - drug therapy</topic><topic>Stomatitis - prevention & control</topic><topic>Taste</topic><topic>Transplantation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Parkhideh, Sayeh</creatorcontrib><creatorcontrib>Zeraatkar, Mohadeseh</creatorcontrib><creatorcontrib>Moradi, Omid</creatorcontrib><creatorcontrib>Hajifathali, Abbas</creatorcontrib><creatorcontrib>Mehdizadeh, Mahshid</creatorcontrib><creatorcontrib>Tavakoli-Ardakani, Maria</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Social Sciences Premium Collection</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Social Science Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Sociology Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Social Science Database</collection><collection>Sociology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Supportive care in cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Parkhideh, Sayeh</au><au>Zeraatkar, Mohadeseh</au><au>Moradi, Omid</au><au>Hajifathali, Abbas</au><au>Mehdizadeh, Mahshid</au><au>Tavakoli-Ardakani, Maria</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial</atitle><jtitle>Supportive care in cancer</jtitle><stitle>Support Care Cancer</stitle><addtitle>Support Care Cancer</addtitle><date>2022</date><risdate>2022</risdate><volume>30</volume><issue>1</issue><spage>251</spage><epage>257</epage><pages>251-257</pages><issn>0941-4355</issn><eissn>1433-7339</eissn><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</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>34259920</pmid><doi>10.1007/s00520-021-06409-0</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0941-4355 |
| ispartof | Supportive care in cancer, 2022, Vol.30 (1), p.251-257 |
| issn | 0941-4355 1433-7339 |
| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Analysis Antibiotics Azithromycin Azithromycin - adverse effects Cancer Chemotherapy Clinical trials Disease management Disease prevention Drug therapy Health aspects Hematopoietic Stem Cell Transplantation - adverse effects Hematopoietic stem cells Humans Iran Medical centers Medicine Medicine & Public Health Mucositis Nursing Nursing Research Oncology Oral medication Original Article Pain Medicine Rehabilitation Medicine Single-Blind Method Stem cell research Stem cell transplantation Stem cells Stomatitis Stomatitis - chemically induced Stomatitis - drug therapy Stomatitis - prevention & control Taste Transplantation |
| title | 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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