← Back to Search

Miracle Mouthwash Plus Hydrocortisone for Mouth Sore

Phase 2
Waitlist Available
Led By Joyce A. O'Shaughnessy, MD
Research Sponsored by US Oncology Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 64 weeks
Awards & highlights

Study Summary

This trial is testing two different ways to treat mouth sores that can be a side effect of taking everolimus with an aromatase inhibitor. One is a mouth rinse with hydrocortisone, and the other is a mouth rinse with prednisolone.

Eligible Conditions
  • Mouth Sore
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~64 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 64 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Grade ≥ 2 stomatitis
Secondary outcome measures
Incidence of all side effects
Percentage of patients requiring dose interruptions and/or dose reductions of everolimus
Reduction in pain score on questionnaires
Other outcome measures
Time to Disease Progression of next anti-cancer therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Miracle Mouthwash plus HydrocortisoneExperimental Treatment1 Intervention
Miracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks.
Group II: PrednisoloneActive Control1 Intervention
Prednisolone oral solution 15 mg/5 ml; swish and expectorate 10cc (10 mL) 4 times per day, every day for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miracle Mouthwash Plus Hydrocortisone
2014
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

US Oncology ResearchLead Sponsor
37 Previous Clinical Trials
17,358 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,857 Previous Clinical Trials
4,197,697 Total Patients Enrolled
Joyce A. O'Shaughnessy, MDPrincipal InvestigatorUS Oncology Research, McKesson Specialty Health
3 Previous Clinical Trials
339 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
12 sites incl Yakima, WA, Boulder, CO, and Austin, TX
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
2014. "Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02229136.
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top