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Alliance A221701


Clinical Trial Title

Phase III placebo-controlled trial to evaluate dexamethasone use for everolimus-induced oral stomatitis: prevention versus early treatment approaches

Trial Status

Closed to Enrollment

Start Date

February 14, 2019

Trial Type

Cancer - Adult Oncology


This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.

Eligibility Criteria

Eligibility 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.
  • Prior Treatment
  •     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.
  • ECOG Performance Status 0, 1 or 2.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Regan Look, MD

Contact Name

Oncology Clinical Research



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Last Updated: Wednesday, January 27, 2021 12:56:56 PM