A randomised controlled trial of Caphosol mouthwash in management of radiation-induced mucositis in head and neck cancer
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Purpose
This phase III, non-blinded, parallel-group, randomised controlled study evaluated the efficacy of Caphosol mouthwash in the management of radiation-induced oral mucositis (OM) in patients with head and neck cancer (HNC) undergoing radical (chemo)radiotherapy.
Patients and methods
Eligible patients were randomised at 1:1 to Caphosol plus standard oral care (intervention) or standard oral care alone (control), stratified by radiotherapy technique and use of concomitant chemotherapy. Patients in the intervention arm used Caphosol for 7 weeks: 6 weeks during and 1-week post-radiotherapy. The primary endpoint was the incidence of severe OM (CTCAE ⩾grade 3) during and up to week 8 post-radiotherapy. Secondary endpoints include pharyngeal mucositis, dysphagia, pain and quality of life.
Results
The intervention (n = 108) and control (n = 107) arms were well balanced in terms of patient demographics and treatment characteristics. Following exclusion of patients with missing data, 210 patients were available for analysis. The incidence of severe OM did not differ between the intervention and control arms (64.1% versus 65.4%, p = 0.839). Similarly, no significant benefit was observed for other secondary endpoints. Overall, compliance with the recommended frequency of Caphosol was low.
Conclusion
Caphosol did not reduce the incidence or duration of severe OM during and after radiotherapy in HNC.
This phase III, non-blinded, parallel-group, randomised controlled study evaluated the efficacy of Caphosol mouthwash in the management of radiation-induced oral mucositis (OM) in patients with head and neck cancer (HNC) undergoing radical (chemo)radiotherapy.
Patients and methods
Eligible patients were randomised at 1:1 to Caphosol plus standard oral care (intervention) or standard oral care alone (control), stratified by radiotherapy technique and use of concomitant chemotherapy. Patients in the intervention arm used Caphosol for 7 weeks: 6 weeks during and 1-week post-radiotherapy. The primary endpoint was the incidence of severe OM (CTCAE ⩾grade 3) during and up to week 8 post-radiotherapy. Secondary endpoints include pharyngeal mucositis, dysphagia, pain and quality of life.
Results
The intervention (n = 108) and control (n = 107) arms were well balanced in terms of patient demographics and treatment characteristics. Following exclusion of patients with missing data, 210 patients were available for analysis. The incidence of severe OM did not differ between the intervention and control arms (64.1% versus 65.4%, p = 0.839). Similarly, no significant benefit was observed for other secondary endpoints. Overall, compliance with the recommended frequency of Caphosol was low.
Conclusion
Caphosol did not reduce the incidence or duration of severe OM during and after radiotherapy in HNC.
Date Issued
2017-02
Date Acceptance
2016-06-26
Citation
Radiotherapy and Oncology, 2017, 122 (2), pp.207-211
ISSN
0167-8140
Publisher
Elsevier BV
Start Page
207
End Page
211
Journal / Book Title
Radiotherapy and Oncology
Volume
122
Issue
2
Copyright Statement
© 2016 Elsevier Ireland Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/
Identifier
https://www.sciencedirect.com/science/article/pii/S0167814016311744?via%3Dihub
Subjects
Oncology & Carcinogenesis
0299 Other Physical Sciences
1112 Oncology and Carcinogenesis
Publication Status
Published
Date Publish Online
2016-07-05