Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
(MIST Trial)
Recruiting in Palo Alto (17 mi)
+318 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Alliance for Clinical Trials in Oncology
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
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
Inclusion Criteria
The patient has not received chemotherapy or any other agent that is known to cause mucositis or stomatitis
There has been no history of candida infection (thrush) in the last 3 months.
The person is not being treated with corticosteroids at the moment.
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Treatment Details
Interventions
- Dexamethasone (Corticosteroid)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (dexamethasone)Experimental Treatment4 Interventions
Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
Group II: Group II (placebo)Placebo Group4 Interventions
Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Dexamethasone for:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
🇺🇸 Approved in United States as Dexamethasone for:
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
🇨🇦 Approved in Canada as Dexamethasone for:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
🇯🇵 Approved in Japan as Dexamethasone for:
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Holy Cross HospitalFort Lauderdale, FL
Southern Illinois University School of MedicineSpringfield, IL
Mercy Health Saint Mary'sGrand Rapids, MI
Unity HospitalFridley, MN
More Trial Locations
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Who Is Running the Clinical Trial?
Alliance for Clinical Trials in OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator