Wong, K.H., Kuciejewska, A., Sharabiani, M.T., Ng-Cheng-Hin, B., Hoy, S., Hurley, T., . . . Newbold, K.L. (2016). A randomised controlled trial of Caphosol mouthwash in management of radiation-induced mucositis in head and neck cancer. Radiotherapy and Oncology, 122, 207–211.
To evaluate the efficacy of Caphosol mouthwash in the management of patients with head and neck cancer receiving (chemo)radiotherapy who have radiation-induced oral mucositis (OM)
Prior to receiving (chemo)radiotherapy, patients were randomized 1:1 to receive a standard oral care regimen (control) with or without Caphosol mouthwash. Those patients randomized to Caphosol used it from week 1–6 of radiation and then one week postradiation, at least four times per day, but could be increased up to 10 times per day per the patient or physician discretion. Other interventions for symptom control were allowed during the study. The patients randomized to the control arm received standard OM treatment per the institutions guidelines, which consisted of normal saline rinses at least four times per day, fluoride toothpaste with brushing, and aspirin mouthwash three times per day. Training on the use of Caphosol was provided by EUSA Pharma.
PHASE OF CARE: Active antitumor treatment
Phase III, single institution, non-blinded, randomized, controlled trial
Patients were assessed at baseline and prospectively every week for six weeks during radiation therapy and until four weeks postradiation therapy. Physicians trained on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, performed the scoring of radiation-induced adverse events. Quality of life was assessed at baseline, week 4 of radiation therapy, week 4 of postradiation therapy, and week 8 of postradiation therapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Model (EORTC QLQ-C30), version 3.0, and the Quality of Life Questionnaire Head and Neck Module (QLQ-HN35).
In this large study, prophylactic Caphosol mouthwashes with standard OM treatment did not show a benefit versus standard OM treatment alone in reducing the incidence of OM or shortening the duration of OM in patients receiving (chemo)radiotherapy for head and neck cancer.
No evidence suggests that this intervention would benefit the type of patients studied. The cost of Caphosol would not be warranted, and its use could actually negatively affect patients because of the poor taste and potential for nausea.