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 in | British journal of cancer Vol. 116; no. 1; pp. 21 - 27 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
London
Nature Publishing Group UK
03.01.2017
Nature Publishing Group |
Subjects | |
Online Access | Get full text |
ISSN | 0007-0920 1532-1827 1532-1827 |
DOI | 10.1038/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. |
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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 |
Author_xml | – sequence: 1 givenname: Nathaniel surname: Treister fullname: Treister, Nathaniel email: ntreister@partners.org organization: Division of Oral Medicine and Dentistry, Brigham and Women’s Hospital, Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine – sequence: 2 givenname: Michael surname: Nieder fullname: Nieder, Michael organization: Blood and Marrow Transplant Department, Moffitt Cancer Center, Tampa, FL and Johns Hopkins All Children’s Hospital – sequence: 3 givenname: Christina surname: Baggott fullname: Baggott, Christina organization: Pediatric Hematology-Oncology, Stanford Medical Center – sequence: 4 givenname: Ellen surname: Olson fullname: Olson, Ellen organization: Aflac Cancer and Blood Disorders Service, Children’s Healthcare of Atlanta – sequence: 5 givenname: Lu surname: Chen fullname: Chen, Lu organization: Children’s Oncology Group – sequence: 6 givenname: Ha surname: Dang fullname: Dang, Ha organization: Children’s Oncology Group, Department of Preventive Medicine, University of Southern California – sequence: 7 givenname: Mark surname: Krailo fullname: Krailo, Mark organization: Children’s Oncology Group, Department of Preventive Medicine, University of Southern California – sequence: 8 givenname: Amanda surname: August fullname: August, Amanda organization: Children’s Mercy Hospital – sequence: 9 givenname: Lillian surname: Sung fullname: Sung, Lillian organization: Division of Haematology/Oncology, The Hospital for Sick Children |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27875526$$D View this record in MEDLINE/PubMed |
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Keywords | oral mucositis hematopoietic cell transplantation pediatrics |
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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 |
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