Status:
TERMINATED
Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 stomatiti...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if the initiation of dexamethasone at the start of everolimus treatment prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the initi...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03839940
Start Date
June 3 2019
End Date
August 3 2022
Last Update
January 29 2025
Active Locations (319)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401
3
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
4
PCR Oncology
Arroyo Grande, California, United States, 93420