title: Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation.
abstract: The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning, reduces the duration of severe oral mucositis (OM) compared with placebo among children and adolescents undergoing haematopoietic cell transplantation (HCT).
  
  
  
  This was a Children's Oncology Group multicentre randomised double-blinded placebo-controlled clinical trial. Patients between the ages of 4 and 21 years who were scheduled to undergo myeloablative HCT for any indication were randomised to Caphosol or placebo saline rinses four times daily from initiation of conditioning through day +20. Subjects were assessed daily for OM using the World Health Organisation (WHO) Oral Toxicity Scale, Mouth Pain Categorical Scale (0-10) and the Oral Mucositis Daily Questionnaire (OMDQ). The primary end point was duration of severe OM (WHO ⩾3).
  
  
  
  The study enrolled 220 participants with a median age of 13.7 years (range 4.0-21.9); 163 (74%) received allogeneic HCT. The mean (±s.d.) duration of severe OM was not reduced among Caphosol (4.5±5.0 days) vs placebo (4.5±4.8; P=0.99) recipients. The incidence of severe OM in the Caphosol and placebo arms was 63% (57 out of 91) and 68% (62 out of 91), respectively (P=0.44). There were no significant differences in any of the secondary end points between the groups.
  
  
  
  Caphosol did not reduce severe OM when compared with placebo among children and adolescents undergoing myeloablative HCT. Studies to identify effective interventions for OM are needed in this population.
authors.affiliation: Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA.|Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Treister
authors.affiliation: Blood and Marrow Transplant Department, Moffitt Cancer Center, Tampa, FL and Johns Hopkins All Children's Hospital, St Petersburg, FL, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Nieder
authors.affiliation: Pediatric Hematology-Oncology, Stanford Medical Center, Stanford, CA, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Baggott
authors.affiliation: Aflac Cancer and Blood Disorders Service, Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Ellen
authors.initials: E
authors.lastname: Olson
authors.affiliation: Children's Oncology Group, Monrovia, CA, USA.
authors.forename: Lu
authors.initials: L
authors.lastname: Chen
authors.affiliation: Children's Oncology Group, Monrovia, CA, USA.|Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Ha
authors.initials: H
authors.lastname: Dang
authors.affiliation: Children's Oncology Group, Monrovia, CA, USA.|Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Krailo
authors.affiliation: Children's Mercy Hospital, Kansas City, MO, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: August
authors.affiliation: Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
mesh_terms: D000293:Adolescent; D000328:Adult; D002130:Calcium Phosphates / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D006982:Hypertonic Solutions / Q000627:therapeutic use*; D008297:Male; D019653:Myeloablative Agonists / Q000627:therapeutic use*; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002130:Calcium Phosphates; D006982:Hypertonic Solutions; D019653:Myeloablative Agonists; C020243:calcium phosphate