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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02229136
Recruitment Status : Active, not recruiting
First Posted : August 29, 2014
Last Update Posted : October 1, 2018
Novartis Pharmaceuticals
Information provided by (Responsible Party):
US Oncology Research

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
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 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Incidence of all side effects [ Time Frame: 64 weeks ]
    Determination of the incidence of adverse events (all grades)

  2. 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.

  3. 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).

Other Outcome Measures:
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02229136

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

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Responsible Party: US Oncology Research Identifier: NCT02229136     History of Changes
Other Study ID Numbers: 13026
CRAD001JUS240T ( Other Identifier: Novartis )
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
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:
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Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Breast Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents