Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT03839940

Run by

Alliance for Clinical Trials in Oncology

People needed

39

Starts

2019-06-03

Expected to finish

2022-08-03

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

Where it is running

• Kingman Regional Medical Center — Kingman, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• PCR Oncology — Arroyo Grande, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Epic Care Cyberknife Center — Walnut Creek, California, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
• Kootenai Medical Center — Coeur d'Alene, Idaho, United States
• Walter Knox Memorial Hospital — Emmett, Idaho, United States
• Idaho Urologic Institute-Meridian — Meridian, Idaho, United States
• Saint Alphonsus Medical Center-Nampa — Nampa, Idaho, United States
• Kootenai Cancer Center — Post Falls, Idaho, United States
• Kootenai Cancer Clinic — Sandpoint, Idaho, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Memorial Hospital of Carbondale — Carbondale, Illinois, United States
• SIH Cancer Institute — Carterville, Illinois, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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