Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
|ClinicalTrials.gov Identifier: NCT02229136|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2014
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stomatitis Oral Mucositis Neoplasm of the Breast Malignant Tumor of Breast||Drug: Miracle Mouthwash Plus Hydrocortisone Drug: Prednisolone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Miracle Mouthwash (MMW) Plus Hydrocortisone and Prednisolone Mouth Rinse as Prophylaxis for Everolimus-Associated Stomatitis|
|Actual Study Start Date :||September 4, 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: Miracle Mouthwash plus Hydrocortisone
Miracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks.
Drug: Miracle Mouthwash Plus Hydrocortisone
Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml)
Active Comparator: Prednisolone
Prednisolone oral solution 15 mg/5 ml; swish and expectorate 10cc (10 mL) 4 times per day, every day for 12 weeks.
Prednisolone oral solution 15 mg/5 ml
- Incidence of Grade ≥ 2 stomatitis [ Time Frame: 12 weeks ]The primary objective of the study is to determine the incidence of Grade ≥ 2 stomatitis in patients undergoing treatment with an aromatase inhibitor plus everolimus (AIE) when treated with either Miracle Mouthwash (MMW) plus hydrocortisone or with a prednisolone mouth rinse during the first 12 weeks of treatment.
- Incidence of all side effects [ Time Frame: 64 weeks ]Determination of the incidence of adverse events (all grades)
- Percentage of patients requiring dose interruptions and/or dose reductions of everolimus [ Time Frame: 64 weeks ]Determination of the percentage of patients requiring dose interruptions and/or dose reductions of everolimus, as well as the percentage of patients discontinuing therapy with everolimus due to toxicity.
- Reduction in pain score on questionnaires [ Time Frame: 12 weeks ]Evaluation of the impact of MMW plus hydrocortisone or a prednisolone mouth rinse on the duration and severity of stomatitis, as assessed by the Oral Stomatitis Daily Questionnaire (OSDQ).
- Time to Disease Progression of next anti-cancer therapy [ Time Frame: 64 weeks ]An exploratory objective is to assess patient response to the next anti-cancer therapy of physician's choice following progression on AIE, including duration of response and sites of progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229136
|United States, Texas|
|12 sites incl Yakima, WA, Boulder, CO, and Austin, TX|
|US, Texas, United States|
|Principal Investigator:||Vicky E. Jones, MD||US Oncology Research, McKesson Specialty Health|