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.
Study 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).
Intervention Characteristics/Basic Study Process
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. Dexamethasone oral solution was used for two minutes, four times a day.
Sample Characteristics
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. The average age of the 92/86 female participants was 61 years.
Setting
This was a multi-center study in the U.S.
Study Design
It was a single-arm phase 2 study
Measurement Instruments/Methods
Stomatitis was graded with a composite score of CTCAE 4.0, visual analogue scale, and Normalcy of Diet Scale.
Results
The primary endpoint of the incidence of Grade 2 or worse OM was significantly reduced by proactive oral care use of alcohol-free dexamethasone oral solution (SWISH). At 8 weeks, incidence of Grade 2 mucositis was 2% (dexamethasone) versus 33% for historical controls.
Conclusions
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.
Limitations
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. There were no long-term results.
Nursing Implications
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.