Rugo, H.S., Seneviratne, L., Beck, J.T., Glaspy, J.A., Peguero, J.A., Pluard, T.J., . . . Litton, J.K. (2017). Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): A single-arm, phase 2 trial. Lancet Oncology, 18, 654–662.

PURPOSE: Prevention of combination drug therapy-induced OM (stomatitis) This is the second clinical trial supported by Novartis in patients taking combination drug therapy (everolimus and exemestane).

TYPES OF PATIENTS ADDRESSED: Patients with hormone receptor-positive, HER2-negative metastatic breast cancer 

RESOURCE TYPE: Evidence-based guideline

DATABASES USED: PubMed   

INCLUSION CRITERIA: Metastatic breast cancer with hormone receptor-positive, HER2-negative

EXCLUSION CRITERIA: All other types of cancer

PHASE OF CARE: Late effects and survivorship

This is the second clinical trial performed by Novartis to eliminate dose interruption of everolimus tablets in combination therapy for women with hormone receptor-positive, HER2-negative metastatic breast cancer. Twenty-three investigational sites based in the United States participated. The average age of the 92/86 female participants was 61 years. It was a single-arm phase 2 study. The primary endpoint was the incidence of grade 2 or worse OM was significantly reduced by proactive oral care use of alcohol-free dexamethasone oral solution (SWISH).

This is the first and largest OM prevention study completed that combines therapeutic management with proactive patient engagement to reduce the incidence of OM in patients who are postmenopausal and receiving combination pill therapy(everolimus and exemestane) as treatment for hormone receptor-positive, HER2-negative metastatic breast cancer. The use of dexamethasone oral solution for two minutes, four times a day, will stop OM from occurring or reduce the severity. It is used for eight weeks or longer if results are positive.

The primary limitation is it is for only one targeted group and for one target drug. The clinical trial is high strength and high quality. There could not be a control group due to the fact that the investigators did not find it ethical for patients to suffer with OM. Novartis is the manufacture of dexamethasone oral rinse and gives free eight-week supplies.

The nursing implication is to teach an oral care protocol to all patients with cancer and ask for more clinical trials for patients with other types of cancer or receiving other treatments. The SWISH trial found that a commercially available, inexpensive, well tolerated dexamethasone oral rinse is an effective intervention in the prevention of OM in women with HER2-negative metastatic breast cancer treated with everolimus.