Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|