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Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus

NCT02229136 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-12-01

No results posted yet for this study

Summary

This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention or treatment of everolimus-associated stomatitis (mouth sores) in postmenopausal patients undergoing treatment with an aromatase inhibitor plus everolimus. An exploratory analysis will also evaluate patient response to next anti-cancer therapy of physician's choice following discontinuation of therapy with an aromatase inhibitor plus everolimus.

Conditions

  • Stomatitis
  • Oral Mucositis
  • Neoplasm of the Breast
  • Malignant Tumor of Breast

Interventions

DRUG

Miracle Mouthwash Plus Hydrocortisone

Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml)

DRUG

Prednisolone

Prednisolone oral solution 15 mg/5 ml

Sponsors & Collaborators

Principal Investigators

  • Joyce A. O'Shaughnessy, MD · US Oncology Research, McKesson Specialty Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-04
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • United States

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229136 on ClinicalTrials.gov