Stage IV Breast Cancer Clinical Trial
Official title:
Phase II Randomized Trial of Mugard Compared With Best Supportive Care for Prevention and Treatment of Stomatitis in Women With Hormone Receptor Positive Breast Cancer Initiating Treatment With Everolimus-based Endocrine Therapy.
This randomized phase II trial studies how well mucoadhesive oral wound rinse works in preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed by surgery receiving everolimus. Mucoadhesive oral wound rinse may help prevent symptoms of stomatitis, or mouth sores, in patients receiving everolimus.
PRIMARY OBJECTIVES:
I. Evaluate whether use of prophylactic MuGard (mucoadhesive oral wound rinse) in
participants being treated with everolimus will reduce the rate of stomatitis.
SECONDARY OBJECTIVES:
I. Compare symptoms from mouth sores in patients receiving MuGard compared with those
receiving best supportive care.
II. Evaluate the rate of everolimus dose adjustment or therapy discontinuation as a result of
stomatitis in participants treated with MuGard prophylaxis versus best supportive care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive mucoadhesive oral wound rinse orally (PO) as a gentle swish for 30-60
seconds 3-6 times daily beginning on day 1 of everolimus therapy and continuing for up to 6
months in the absence of unacceptable toxicity.
ARM II: Patients receive no intervention.
After completion of study treatment, patients are followed up within 7 days.
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