Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial

The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as stand...

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Published in:	Bone marrow transplantation (Basingstoke) Vol. 54; no. 9; pp. 1482 - 1488
Main Authors:	Johansson, Jan-Erik, Bratel, John, Hardling, Mats, Heikki, Lena, Mellqvist, Ulf-Henrik, Hasséus, Bengt
Format:	Journal Article
Language:	English
Published:	London Nature Publishing Group UK 01-09-2019 Nature Publishing Group
Subjects:	692/699/1541/1990/804 692/700/565/2194 Analysis Autografts Bone marrow Cell Biology Clinical Medicine Clinical trials Cold Comparative studies Cryotherapy Dosage and administration Females Health aspects Hematology Hematopoietic stem cells Internal Medicine Klinisk medicin Males Medicine Medicine & Public Health Melphalan Mucosa Mucositis Multiple myeloma Myeloma Prophylaxis Public Health Quality of life Randomization Side effects Stem cell transplantation Stem Cells Toxicity Transplantation
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Abstract	The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34–69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h ( N = 46) or 2 h ( N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI −0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597).
AbstractList	The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34–69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h (N = 46) or 2 h (N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI −0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597). © 2019, Springer Nature Limited. The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34–69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h ( N = 46) or 2 h ( N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI −0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597). The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34-69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h (N = 46) or 2 h (N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI -0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597). The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34–69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h (N = 46) or 2 h (N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI −0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597).
Audience	Academic
Author	Johansson, Jan-Erik Hasséus, Bengt Bratel, John Hardling, Mats Mellqvist, Ulf-Henrik Heikki, Lena
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Cites_doi	10.1038/bmt.2016.20 10.1038/bmt.2015.6 10.1111/j.1365-2125.2010.03638.x 10.1038/sj.bmt.1705471 10.1002/cpt.644 10.1200/JCO.2001.19.8.2201 10.1016/j.bbmt.2015.07.032 10.1016/j.jpainsymman.2011.08.012 10.2165/00003088-200544100-00004 10.1200/JCO.1991.9.3.449 10.1016/S1470-2045(14)70442-5 10.1002/(SICI)1097-0142(19990515)85:10<2103::AID-CNCR2>3.0.CO;2-0 10.1111/ejh.12386 10.1002/cncr.22484 10.1038/bmt.2016.207 10.1038/sj.bmt.1705494 10.1038/sj.bmt.1705384 10.1002/cncr.28592 10.1182/blood.V120.21.4265.4265 10.6004/jnccn.2008.2001 10.1093/annonc/mdr391 10.1002/14651858.CD000978.pub5
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Snippet	The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts...
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SubjectTerms	692/699/1541/1990/804 692/700/565/2194 Analysis Autografts Bone marrow Cell Biology Clinical Medicine Clinical trials Cold Comparative studies Cryotherapy Dosage and administration Females Health aspects Hematology Hematopoietic stem cells Internal Medicine Klinisk medicin Males Medicine Medicine & Public Health Melphalan Mucosa Mucositis Multiple myeloma Myeloma Prophylaxis Public Health Quality of life Randomization Side effects Stem cell transplantation Stem Cells Toxicity Transplantation
Title	Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial
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