Clinical Trials

Inclusion Criteria: 

• Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without an endocrine agent.
• Patients about to receive everolimus for off label use for any cancer are also eligible. 
• Not currently receiving chemotherapy or any other agent known to cause mucositis or stomatitis.
  • Trastuzumab and ovarian function suppression are allowed. 
• Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed at least 2 weeks prior to registration. 
• Not currently suffering from stomatitis/mucositis or mouth ulcers.
• Patients should not have had any stomatitis or mouth pain for at least 7 days prior to registration. 
• Patients should not receive any other agent which would be considered treatment for stomatitis or impact the primary endpoint. 
• No history of candida infection (thrush) within the last 3 months. 
• Not currently being treated with corticosteroids.
• No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%; although A1C is not needed for all patients, hemoglobin (Hgb)A1C < 8 is required for everyone with diabetes or suspected diabetes. 
• Patients must be able to read and comprehend English.
  • Local translation, including verbal translation of professionals (PROs) is not permitted.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
• Women of childbearing potential only:
  • A negative pregnancy test done ≤ 7 days prior to registration. 

Exclusion Criteria:

• Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.