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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Bibliographic Details
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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Summary:	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).
ISSN:	0268-3369 1476-5365
DOI:	10.1038/s41409-019-0468-6