Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation

Background: 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 transpl...

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Published inBritish journal of cancer Vol. 116; no. 1; pp. 21 - 27
Main Authors Treister, Nathaniel, Nieder, Michael, Baggott, Christina, Olson, Ellen, Chen, Lu, Dang, Ha, Krailo, Mark, August, Amanda, Sung, Lillian
Format Journal Article
LanguageEnglish
Published London Nature Publishing Group UK 03.01.2017
Nature Publishing Group
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ISSN0007-0920
1532-1827
1532-1827
DOI10.1038/bjc.2016.380

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Abstract Background: 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). Methods: 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). Results: 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. Conclusions: 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.
AbstractList 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.
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).BACKGROUNDThe 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).METHODSThis 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.RESULTSThe 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.CONCLUSIONSCaphosol 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.
Background: 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). Methods: 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 [egs]3). Results: 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 ( plus or minus s.d.) duration of severe OM was not reduced among Caphosol (4.5 plus or minus 5.0 days) vs placebo (4.5 plus or minus 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. Conclusions: 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.
Background: 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). Methods: 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). Results: 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. Conclusions: 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.
Background: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).Methods: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 [= or >, slanted]3).Results: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.Conclusions: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.
Author Olson, Ellen
Dang, Ha
Krailo, Mark
August, Amanda
Chen, Lu
Treister, Nathaniel
Sung, Lillian
Nieder, Michael
Baggott, Christina
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  organization: Pediatric Hematology-Oncology, Stanford Medical Center
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  fullname: Olson, Ellen
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  organization: Division of Haematology/Oncology, The Hospital for Sick Children
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Copyright Nature Publishing Group Jan 3, 2017
Copyright © 2016 Cancer Research UK 2016 Cancer Research UK
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Keywords oral mucositis
hematopoietic cell transplantation
pediatrics
Language English
License From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0
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Snippet Background: The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning,...
The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning, reduces the...
Background:The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning,...
Background: The primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning,...
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SubjectTerms 631/92/436/108
692/699/3020/3025
692/699/67/2332
692/700/565/545/576/1955
Adolescent
Adult
Biomedical and Life Sciences
Biomedicine
Calcium Phosphates - therapeutic use
Cancer
Cancer Research
Child
Child, Preschool
Clinical Study
Clinical trials
Drug dosages
Drug Resistance
Epidemiology
FDA approval
Female
Hematopoietic Stem Cell Transplantation - adverse effects
Hospitals
Humans
Hypertonic Solutions - therapeutic use
Male
Medicine
Molecular Medicine
Morphine
Mucositis
Myeloablative Agonists - therapeutic use
Oncology
Pediatrics
Prevention
Stomatitis - etiology
Stomatitis - prevention & control
Teenagers
Transplantation Conditioning - adverse effects
Transplantation Conditioning - methods
Transplantation, Homologous
Transplants & implants
Treatment Outcome
Young Adult
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Title Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation
URI https://link.springer.com/article/10.1038/bjc.2016.380
https://www.ncbi.nlm.nih.gov/pubmed/27875526
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