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.

• N = 215   
• MEAN AGE = 58.8 years (SD = 10.6)
• MALES: 74.9%, FEMALES: 25.1%
• CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Carcinoma of the head and neck receiving (chemo)radiotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria of 18 years of age or older and a Karnofsky Performance Status greater than 70%. Induction chemotherapy and concomitant platinum-based chemotherapy or cetuximab were allowed at the discretion of the physician. Exclusion criteria were previous radiation therapy to head and neck, baseline OM, and carcinoma of the thyroid and larynx. Patients were stratified by type of radiation therapy (unilateral versus bilateral) and whether or not they were receiving chemoradiation versus radiotherapy alone.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Royal Marsden Hospital, UK

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).

• Incidence of grade 3 or higher OM during and up to eight weeks after radiation therapy. This study showed no benefit in the incidence of OM (64.1% Caphosol versus 65.4 control, p = 0.839).

• Duration of grade 3 or higher OM; no difference
• Incidence and duration of pharyngeal mucositis; lower incidence and shorter duration but NCS
• Incidence and duration of severe dysphagia; lower incidence and shorter duration but NCS
• Incidence and duration of severe radiation-induced pain; lower incidence and shorter duration but NCS
• Patient-reported quality of life; no difference

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.

• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Findings not generalizable
• Patients were not stratified by primary site of disease; therefore, patients who were at high risk were not evenly distributed between treatment groups.
• The number of completed quality of life questionnaires were significantly lower than predicted, possibly because of the length and the toxicities patients were experiencing later in the study.
• Patients did not adhere to the prescribed use of Caphosol during the entire study period because of taste, nausea, or perceived lack of benefit.
• Single site—not generalizable

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.