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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by US Oncology Research
Novartis Pharmaceuticals
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
First received: August 26, 2014
Last updated: November 7, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Oral Mucositis
Neoplasm of the Breast
Malignant Tumor of Breast
Drug: Miracle Mouthwash Plus Hydrocortisone
Drug: Prednisolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • Incidence of Grade ≥ 2 stomatitis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

Secondary Outcome Measures:
  • Incidence of all side effects [ Time Frame: 64 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).

Other Outcome Measures:
  • Time to Disease Progression of next anti-cancer therapy [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Prednisolone
Prednisolone oral solution 15 mg/5 ml
Other Names:
  • Millipred
  • Omnipred
  • Orapred
  • Econopred
  • Flo-Pred

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 < 55 years and ≥ 1 year of amenorrhea, with an estradiol assay <20pg/ml
    3. Surgical menopause with bilateral oophorectomy Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LHRH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression;
  5. Planned treatment with an aromatase inhibitor (letrozole, exemestane, or anastrozole) plus everolimus; Note: Prior treatment with an aromatase inhibitor, either for early-stage or metastatic breast cancer, is allowed.
  6. Adequate bone marrow function as shown by: ANC (absolute neutrophil count) ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hb >9 g/dL;
  7. Adequate liver function as shown by:

    1. Total serum bilirubin ≤2.0 mg/dL,
    2. ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) ≤2.5x ULN (upper limit of normal) (≤5x ULN in patients with liver metastases),
    3. INR (International Normalized Ratio) ≤2;
  8. Adequate renal function: serum creatinine ≤1.5x ULN;
  9. Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5x ULN.

    Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication;

  10. Willingness to complete a daily stomatitis symptom questionnaire;
  11. Signed informed consent obtained prior to any screening procedures.

Exclusion Criteria:

  1. Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);
  2. Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus;
  3. Uncontrolled diabetes mellitus as defined by HbA1c (hemoglobin A1c) >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary;
  4. Patient has any severe and/or uncontrolled medical conditions such as:

    1. unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
    2. Symptomatic congestive heart failure of New York Heart Association Class III or IV
    3. active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA (Hepatitis B Virus DNA) and/or positive HbsAg, quantifiable HCV-RNA [Hepatitis C Virus RNA]),
    4. known severely impaired lung function (spirometry and DLCO [Diffusing capacity of the Lung for Carbon Monoxide] 50% or less of normal and O2 saturation 88% or less at rest on room air),
    5. active, bleeding diathesis;
  5. Patient requires chronic treatment with corticosteroids (including inhaled corticosteroids) or other immunosuppressive agents. Topical corticosteroids are allowed;
  6. Known history of HIV seropositivity;
  7. Patient received live attenuated vaccines within 1 week of start of everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG (Bacillus Calmette-Guérin), yellow fever, varicella and TY21a typhoid vaccines;
  8. Patient has a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for ≥3 years;
  9. Patient has a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study;
  10. Patient is currently part of or has participated in any clinical investigation with an investigational drug within 1 month prior to dosing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02229136

Contact: Joshua C. Johnson (281) 863-6731 joshua.johnson@mckesson.com
Contact: Ibett Hynek 281-863-6662 ibett.hynek@mckesson.com

United States, Texas
12 sites incl Yakima, WA, Boulder, CO, and Austin, TX Recruiting
US, Texas, United States
Sponsors and Collaborators
US Oncology Research
Novartis Pharmaceuticals
Principal Investigator: Vicky E. Jones, MD US Oncology Research, McKesson Specialty Health
  More Information

Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT02229136     History of Changes
Other Study ID Numbers: 13026  CRAD001JUS240T 
Study First Received: August 26, 2014
Last Updated: November 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by US Oncology Research:
Mouth sores from chemotherapy
mouth sores
hormone receptor-positive metastatic breast cancer
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Mouth Diseases
Neoplasms by Site
Skin Diseases
Stomatognathic Diseases
Cortisol succinate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Dermatologic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 26, 2016