The effects of a combination oral spray (Mucosamin®) for the prevention of oral mucositis in pediatric patients undergoing hematopoietic stem cell transplantation : a double blind randomized clinical trial
© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature..
PURPOSE: Oral mucositis (OM) is a frequent complication of conditioning regimens for hematopoietic stem cell transplantation (HSCT). Damage to the nuclear and non-nuclear materials of the mucosal cells by the production of Reactive Oxygen Species (ROS) and proinflammatory cytokines could result to development and progression of OM. Previous studies have shown the effectiveness of Mucosamin® oral spray in the management of pain and acceleration of OM healing. The aims of the current study were to evaluate prophylactic effects of Mucosamin® oral spray in reducing the incidence and severity of OM in pediatric patients undergoing allogeneic HSCT.
METHOD: The current study was designed as a double-blind, placebo-controlled randomized clinical trial. Sixty patients were enrolled in the study and received placebo or Mucosamin® spray. Patients in both groups used sprays 4 times daily. Product application was begun at the time of initiation of conditioning regimen and was continued for 14 days.
RESULTS: Mucosamin® significantly reduced incidence and severity of OM compared to the placebo (P values: 0.027 and 0.035, respectively). This product could also decrease OM duration and delay OM onset (P values: 0.007 and 0.006, respectively).
CONCLUSION: Mucosamin® could effectively reduce incidence, severity, and duration of OM and delay OM onset in pediatric patients undergoing allogeneic HSCT.
TRIAL REGISTRATION: The study protocol was registered in the Iranian Registry of Clinical Trials under the registry number IRCT20190917044805N1.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:30 |
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| Enthalten in: |
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer - 30(2022), 10 vom: 22. Okt., Seite 7963-7972 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shahrabi, Marzieh [VerfasserIn] |
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| Links: |
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| Themen: |
Allogenic hematopoietic transplant |
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| Anmerkungen: |
Date Completed 28.09.2022 Date Revised 28.09.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s00520-022-07231-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM342538993 |
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| 100 | 1 | |a Shahrabi, Marzieh |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The effects of a combination oral spray (Mucosamin®) for the prevention of oral mucositis in pediatric patients undergoing hematopoietic stem cell transplantation |b a double blind randomized clinical trial |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. | ||
| 520 | |a PURPOSE: Oral mucositis (OM) is a frequent complication of conditioning regimens for hematopoietic stem cell transplantation (HSCT). Damage to the nuclear and non-nuclear materials of the mucosal cells by the production of Reactive Oxygen Species (ROS) and proinflammatory cytokines could result to development and progression of OM. Previous studies have shown the effectiveness of Mucosamin® oral spray in the management of pain and acceleration of OM healing. The aims of the current study were to evaluate prophylactic effects of Mucosamin® oral spray in reducing the incidence and severity of OM in pediatric patients undergoing allogeneic HSCT | ||
| 520 | |a METHOD: The current study was designed as a double-blind, placebo-controlled randomized clinical trial. Sixty patients were enrolled in the study and received placebo or Mucosamin® spray. Patients in both groups used sprays 4 times daily. Product application was begun at the time of initiation of conditioning regimen and was continued for 14 days | ||
| 520 | |a RESULTS: Mucosamin® significantly reduced incidence and severity of OM compared to the placebo (P values: 0.027 and 0.035, respectively). This product could also decrease OM duration and delay OM onset (P values: 0.007 and 0.006, respectively) | ||
| 520 | |a CONCLUSION: Mucosamin® could effectively reduce incidence, severity, and duration of OM and delay OM onset in pediatric patients undergoing allogeneic HSCT | ||
| 520 | |a TRIAL REGISTRATION: The study protocol was registered in the Iranian Registry of Clinical Trials under the registry number IRCT20190917044805N1 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Allogenic hematopoietic transplant | |
| 650 | 4 | |a Hyaluronic acid | |
| 650 | 4 | |a Mucosamin® | |
| 650 | 4 | |a Oral mucositis | |
| 650 | 4 | |a Pediatric | |
| 650 | 7 | |a Cytokines |2 NLM | |
| 650 | 7 | |a Oral Sprays |2 NLM | |
| 650 | 7 | |a Reactive Oxygen Species |2 NLM | |
| 700 | 1 | |a Solduzian, Mohammad |e verfasserin |4 aut | |
| 700 | 1 | |a Babaie, Molouk Hadji |e verfasserin |4 aut | |
| 700 | 1 | |a Mousavi, Seied Asadollah |e verfasserin |4 aut | |
| 700 | 1 | |a Goodarzi, Navid |e verfasserin |4 aut | |
| 700 | 1 | |a Ravari, Nazanin Shabani |e verfasserin |4 aut | |
| 700 | 1 | |a Sadeghi, Kourosh |e verfasserin |4 aut | |
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