Randomized controlled and double-blinded study of Caphosol versus saline oral rinses in pediatric patients with cancer.
Adolescent
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Child
Child, Preschool
Cross-Over Studies
Double-Blind Method
Female
Follow-Up Studies
Humans
Male
Mouthwashes
/ therapeutic use
Neoplasms
/ drug therapy
Prognosis
Prospective Studies
Saline Solution
/ therapeutic use
Stomatitis
/ chemically induced
Caphosol
mucositis
prevention
randomized
saline
Journal
Pediatric blood & cancer
ISSN: 1545-5017
Titre abrégé: Pediatr Blood Cancer
Pays: United States
ID NLM: 101186624
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
15
05
2020
accepted:
04
06
2020
pubmed:
30
7
2020
medline:
5
1
2021
entrez:
30
7
2020
Statut:
ppublish
Résumé
Oral mucositis (OM) is a significant side effect of cancer treatment. The purpose of this study was to compare topically administered Caphosol to saline rinses in the prevention of mucositis in pediatric cancer patients. A controlled, double-blinded, and randomized clinical crossover study recruited patients between 2 to 17.99 years of age who were diagnosed with a malignancy and were receiving either high-dose methotrexate (≥1 g/m A total of 56 patients were recruited to the study, of whom 45 were randomized with a median age of 6.5 years (range 2.1-17.1 years). No cases of severe OM were observed. Grade ≥ 3 oral symptoms were present at least once in six (13%) patients during the Caphosol cycle and 13 (29%) patients during the saline cycle (P = .12). The peak of symptom scores was evident at around day 4-7 after administration of the chemotherapy with no marked differences between the rinse solutions. Multivariable regression analysis did not indicate a benefit of using Caphosol over the saline solution. No difference in prevention of oral mucositis was observed between the use of Caphosol or saline rinses.
Sections du résumé
BACKGROUND
Oral mucositis (OM) is a significant side effect of cancer treatment. The purpose of this study was to compare topically administered Caphosol to saline rinses in the prevention of mucositis in pediatric cancer patients.
PROCEDURE
A controlled, double-blinded, and randomized clinical crossover study recruited patients between 2 to 17.99 years of age who were diagnosed with a malignancy and were receiving either high-dose methotrexate (≥1 g/m
RESULTS
A total of 56 patients were recruited to the study, of whom 45 were randomized with a median age of 6.5 years (range 2.1-17.1 years). No cases of severe OM were observed. Grade ≥ 3 oral symptoms were present at least once in six (13%) patients during the Caphosol cycle and 13 (29%) patients during the saline cycle (P = .12). The peak of symptom scores was evident at around day 4-7 after administration of the chemotherapy with no marked differences between the rinse solutions. Multivariable regression analysis did not indicate a benefit of using Caphosol over the saline solution.
CONCLUSIONS
No difference in prevention of oral mucositis was observed between the use of Caphosol or saline rinses.
Substances chimiques
Mouthwashes
0
Saline Solution
0
Banques de données
ClinicalTrials.gov
['NCT02807337']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e28520Informations de copyright
© 2020 Wiley Periodicals LLC.
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