Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02229136 | Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus | PHASE2 | COMPLETED | 104 | — | — | Sep 4, 2014 | Nov 1, 2022 | Dec 1, 2022 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Miracle Mouthwash plus Hydrocortisone | EXPERIMENTAL | Miracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks. |
| Prednisolone | ACTIVE_COMPARATOR | Prednisolone oral solution 15 mg/5 ml; swish and expectorate 10cc (10 mL) 4 times per day, every day for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Miracle Mouthwash Plus Hydrocortisone | DRUG | Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml) |
| Prednisolone | DRUG | Prednisolone oral solution 15 mg/5 ml |
Inclusion Criteria: 1. Age ≥ 18 years; 2. ECOG (Eastern Cooperative Group) Performance status ≤ 2; 3. Histologic or cytologic confirmation of stage IV hormone receptor-positive breast cancer; 4. Postmenopausal status, defined either by: 1. Age ≥ 55 years and ≥ 1 year of amenorrhea 2. Age \< ...