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However, the use of IC may cause adverse reactions and requires water of safe quality to minimize risk of serious infections. This randomized, blinded, parallel group, phase 3 trial was conducted in five Scandinavian centers. Eligible patients were diagnosed with multiple myeloma or lymphoma, scheduled to receive conditioning with high-dose chemotherapy prior to autologous hematopoietic stem cell transplantation (ASCT). Patients were assigned to cooling with IC or a novel intraoral cooling device (ICD). The primary outcome was the highest OM score during the study period, expressed as peak value on the Oral Mucositis Assessment Scale (OMAS\u2013total). When the entire study population (<jats:italic>n<\/jats:italic>\u2009=\u2009172) was analyzed for peak OMAS\u2013total, the two cooling methods were equally effective. However, when the lymphoma group was analyzed separately, the ICD significantly reduced the peak OMAS\u2013total score to a greater extent compared to IC (<jats:italic>x\u0304<\/jats:italic>\u2009\u00b1\u2009SD; 1.77\u2009\u00b1\u20091.59 vs. 3.08\u2009\u00b1\u20091.50; <jats:italic>p<\/jats:italic>\u2009=\u20090.047). Combined with existing evidence, the results of the present trial confirm that CP is an effective method to prevent OM. ClinicalTrials.gov. 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JW, AS, AM, and DEP report personal fees from BrainCool AB. RH reports personal fees from BrainCool AB, The National Swedish Beneficiary Authority (Government), and from EMA (European Medical Agency). FS reports personal fees from Amgen, Takeda, Skylite DX, and from Novartis, grants and personal fees from Celgene\/BMS, Janssen, Oncopeptides and Sanofi, and grants from GSK. M Jontell reports consultation fee from Braincool AB and grants from Braincool AB.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}