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

NCT02229136 | Completed Phase 2 DMC

• 2 other identifiers: 13026CRAD001JUS240T
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomatitis; Oral Mucositis; Neoplasm of the Breast; Malignant Tumor of Breast

Keywords

Mouth sores from chemotherapy; mouth sores; hormone receptor-positive metastatic breast cancer; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥ 2 stomatitis

  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.

  12 weeks

Secondary Outcomes (3)

• Incidence of all side effects

  64 weeks

• Percentage of patients requiring dose interruptions and/or dose reductions of everolimus

  64 weeks

• Reduction in pain score on questionnaires

  12 weeks

Other Outcomes (1)

• Time to Disease Progression of next anti-cancer therapy

  64 weeks

Study Arms (2)

Miracle Mouthwash plus Hydrocortisone

EXPERIMENTAL

Miracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks.

Drug: Miracle Mouthwash Plus Hydrocortisone

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.

Drug: Prednisolone

Interventions

Miracle Mouthwash Plus Hydrocortisone DRUG

Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml)

Miracle Mouthwash plus Hydrocortisone

Prednisolone DRUG

Prednisolone oral solution 15 mg/5 ml

Also known as: Millipred, Omnipred, Orapred, Econopred, Flo-Pred

Prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• ECOG (Eastern Cooperative Group) Performance status ≤ 2;
• Histologic or cytologic confirmation of stage IV hormone receptor-positive breast cancer;
• Postmenopausal status, defined either by:
• Age ≥ 55 years and ≥ 1 year of amenorrhea
• Age \< 55 years and ≥ 1 year of amenorrhea, with an estradiol assay \<20pg/ml
• 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;
• 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.
• 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;
• Adequate liver function as shown by:
• Total serum bilirubin ≤2.0 mg/dL,
• ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) ≤2.5x ULN (upper limit of normal) (≤5x ULN in patients with liver metastases),
• INR (International Normalized Ratio) ≤2;
• Adequate renal function: serum creatinine ≤1.5x ULN;
• Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5x ULN.

You may not qualify if:

• Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);
• Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus;
• 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;
• Patient has any severe and/or uncontrolled medical conditions such as:
• 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
• Symptomatic congestive heart failure of New York Heart Association Class III or IV
• 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 \[Hepatitis C Virus RNA\]),
• 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),
• active, bleeding diathesis;
• Patient requires chronic treatment with corticosteroids (including inhaled corticosteroids) or other immunosuppressive agents. Topical corticosteroids are allowed;
• Known history of HIV seropositivity;
• 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;
• 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;
• 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;
• Patient is currently part of or has participated in any clinical investigation with an investigational drug within 1 month prior to dosing.

Sponsors & Collaborators

• US Oncology Research: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

12 sites incl Yakima, WA, Boulder, CO, and Austin, TX

US, Texas, United States

Location

MeSH Terms

Conditions

Stomatitis; Breast Neoplasms; Oral Ulcer

Interventions

Hydrocortisone; Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienetriols; Pregnadienes

Study Officials

• Joyce A. O'Shaughnessy, MD

  US Oncology Research, McKesson Specialty Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 29, 2014
• Study Start: September 4, 2014
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

US (1)