StomatitisPhase 2NCT02229136
Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
A Phase 2 study testing Miracle Mouthwash Plus Hydrocortisone and Prednisolone in people with Stomatitis and Oral Mucositis, run by US Oncology Research at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stomatitis, Oral Mucositis, Neoplasm of the Breast
- What is being tested?
- Miracle Mouthwash Plus Hydrocortisone and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2014to Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication;
- Willingness to complete a daily stomatitis symptom questionnaire;
- Signed informed consent obtained prior to any screening procedures.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
12 sites incl Yakima, WA, Boulder, CO, and Austin, TX
US, Texas
About this study
Official title: Evaluation of Miracle Mouthwash (MMW) Plus Hydrocortisone and Prednisolone Mouth Rinse as Prophylaxis for Everolimus-Associated Stomatitis
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.
Read the detailed description
Stomatitis, or inflammation of the mucous membranes lining the mouth and throat, is a common side affect associated with chemotherapy and radiation therapy. In addition, stomatitis has been reported in approximately 44% - 64% of patients treated with everolimus (Afinitor PI). However, mTOR (mammalian target of rapamycin) inhibitor-induced stomatitis (mIAS) is a different clinical entity, manifesting more frequently as discrete aphthous-like lesions rather than diffuse inflammation. Oral lesions are typically well demarcated, single or multiple ovoid-shaped ulcerations, with a grayish-white pseudomembrane.
In the BOLERO-2 trial, 56% of patients with MBC (metastatic breast cancer) treated with exemestane plus everolimus developed stomatitis, with 37% developing grade 2/3 stomatitis. These rates are consistent with the rates reported with everolimus therapy in patients with other types of cancers (Afinitor PI). Although this adverse event is reversible, approximately one-fourth of the patients treated with everolimus in the BOLERO-2 trial required dose interruptions or dose reductions, and this may impact the benefit from therapy. Despite the frequency of stomatitis associated with mTOR inhibitor therapy, strategies to prevent and/or ameliorate this painful side effect are not well defined or documented. Expert guidelines on the management of mIAS have been developed, but these guidelines are based on retrospective observational and/or anecdotal evidence, and prospective data on the efficacy of mIAS prevention and management strategies are needed.
There is some evidence to suggest steroid therapy may be helpful in the management of mIAS. Steroid-containing ointments or mouth rises have also been shown to alleviate symptoms in patients with non-chemotherapy associated apthous oral ulcers. Reports on the effectiveness of non-steroid mouthwash formulations have been mixed, but agents that induce a topical anesthetic effect, may help to reduce discomfort and pain.
Thus, the present study has been designed to investigate the effectiveness of two oral rinses (miracle mouth wash [MMW] plus hydrocortisone, vs prednisolone) to prevent or reduce the severity of stomatitis in patients with MBC undergoing treatment with an aromatase inhibitor plus everolimus (AIE).
In addition, because very little is known about the impact of everolimus therapy on response to later lines of treatment for MBC, and preclinical data suggest mTOR inhibition may resensitize cells to endocrine therapy, this study will also assess tumor response to next anti-cancer therapy of physician's choice, including duration of response and sites of progression.
All patients will receive everolimus 10 mg PO QD (by mouth, every day) plus standard dose AI (physician choice of Letrozole, Exemestane, or Anastrozole).
Patients will be randomized 1:1 to 12 weeks of treatment with either:
- Arm 1: MMW plus hydrocortisone
- Arm 2: Prednisolone oral solution (15mg/5ml)
Treatment with the oral rinse will start on Day 1 of everolimus therapy, and will be self-administered. Patients will be instructed to swish and expectorate (cough or spit out) 10ml of the assigned mouth rinse 4 times per day. Patients may also gargle 4 times per day with the assigned rinse for any symptoms of pharyngitis. Patients will also be instructed to fill out the Oral Stomatitis Daily Questionnaire (OSDQ) at home every day.
The incidence of stomatitis, as well as other adverse events, dose reductions/interruptions, and everolimus discontinuation due to toxicity, will be monitored for the first 12 weeks of treatment. After the end of the initial 12 week randomized portion of the study, patients will continue to be followed every 2 months (for up to 1 year following discontinuation of everolimus for progression or intolerable toxicity or progression on subsequent anti-cancer therapy, whichever occurs first) to determine when AIE treatment is discontinued and reason for discontinuation (toxicity, progression), sites of disease progression, response to next anti-cancer therapy of physician's choice (by physician assessment) and duration of response, and sites of disease progression to next anti-cancer therapy following progression on AIE.
- Being tested
- Miracle Mouthwash Plus Hydrocortisone, Prednisolone
- Keywords
- Mouth sores from chemotherapy, mouth sores, hormone receptor-positive metastatic breast cancer, metastatic breast cancer
- Medical subject headings
- Stomatitis, Breast Neoplasms, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miracle Mouthwash Plus HydrocortisoneDrug
Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml)
PrednisoloneDrug
Also called Millipred, Omnipred, Orapred, Econopred
Prednisolone oral solution 15 mg/5 ml
| Study group | Role | What they receive |
|---|---|---|
| Miracle Mouthwash plus Hydrocortisone | Experimental | Miracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks. Receives: 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. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
Incidence of all side effects
Determination of the incidence of adverse events (all grades)
Measured: 64 weeks
Percentage of patients requiring dose interruptions and/or dose reductions of everolimus
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.
Measured: 64 weeks
Reduction in pain score on questionnaires
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study start4 Sep 2014
- Primary completionNov 2022
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Joyce A. O'Shaughnessy, MD, Principal investigator, US Oncology Research, McKesson Specialty Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229136
- Sponsor's protocol ID
- 13026
- Other IDs
- CRAD001JUS240T
- Status last verified
- Nov 2022
- First submitted
- 26 Aug 2014
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Miracle Mouthwash (MMW) Plus Hydrocortisone and Prednisolone Mouth Rinse as Prophylaxis for Everolimus-Associated Stomatitis
- ClinicalTrials.gov ID
- NCT02229136
- Acronym / sponsor ID
- 13026
- Keywords
- Mouth sores from chemotherapy, mouth sores, hormone receptor-positive metastatic breast cancer, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 4 Sep 2014 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stomatitis, or inflammation of the mucous membranes lining the mouth and throat, is a common side affect associated with chemotherapy and radiation therapy. In addition, stomatitis has been reported in approximately 44% - 64% of patients treated with everolimus (Afinitor PI). However, mTOR (mammalian target of rapamycin) inhibitor-induced stomatitis (mIAS) is a different clinical entity, manifesting more frequently as discrete aphthous-like lesions rather than diffuse inflammation. Oral lesions are typically well demarcated, single or multiple ovoid-shaped ulcerations, with a grayish-white pseudomembrane.
In the BOLERO-2 trial, 56% of patients with MBC (metastatic breast cancer) treated with exemestane plus everolimus developed stomatitis, with 37% developing grade 2/3 stomatitis. These rates are consistent with the rates reported with everolimus therapy in patients with other types of cancers (Afinitor PI). Although this adverse event is reversible, approximately one-fourth of the patients treated with everolimus in the BOLERO-2 trial required dose interruptions or dose reductions, and this may impact the benefit from therapy. Despite the frequency of stomatitis associated with mTOR inhibitor therapy, strategies to prevent and/or ameliorate this painful side effect are not well defined or documented. Expert guidelines on the management of mIAS have been developed, but these guidelines are based on retrospective observational and/or anecdotal evidence, and prospective data on the efficacy of mIAS prevention and management strategies are needed.
There is some evidence to suggest steroid therapy may be helpful in the management of mIAS. Steroid-containing ointments or mouth rises have also been shown to alleviate symptoms in patients with non-chemotherapy associated apthous oral ulcers. Reports on the effectiveness of non-steroid mouthwash formulations have been mixed, but agents that induce a topical anesthetic effect, may help to reduce discomfort and pain.
Thus, the present study has been designed to investigate the effectiveness of two oral rinses (miracle mouth wash [MMW] plus hydrocortisone, vs prednisolone) to prevent or reduce the severity of stomatitis in patients with MBC undergoing treatment with an aromatase inhibitor plus everolimus (AIE).
In addition, because very little is known about the impact of everolimus therapy on response to later lines of treatment for MBC, and preclinical data suggest mTOR inhibition may resensitize cells to endocrine therapy, this study will also assess tumor response to next anti-cancer therapy of physician's choice, including duration of response and sites of progression.
All patients will receive everolimus 10 mg PO QD (by mouth, every day) plus standard dose AI (physician choice of Letrozole, Exemestane, or Anastrozole).
Patients will be randomized 1:1 to 12 weeks of treatment with either:
- Arm 1: MMW plus hydrocortisone
- Arm 2: Prednisolone oral solution (15mg/5ml)
Treatment with the oral rinse will start on Day 1 of everolimus therapy, and will be self-administered. Patients will be instructed to swish and expectorate (cough or spit out) 10ml of the assigned mouth rinse 4 times per day. Patients may also gargle 4 times per day with the assigned rinse for any symptoms of pharyngitis. Patients will also be instructed to fill out the Oral Stomatitis Daily Questionnaire (OSDQ) at home every day.
The incidence of stomatitis, as well as other adverse events, dose reductions/interruptions, and everolimus discontinuation due to toxicity, will be monitored for the first 12 weeks of treatment. After the end of the initial 12 week randomized portion of the study, patients will continue to be followed every 2 months (for up to 1 year following discontinuation of everolimus for progression or intolerable toxicity or progression on subsequent anti-cancer therapy, whichever occurs first) to determine when AIE treatment is discontinued and reason for discontinuation (toxicity, progression), sites of disease progression, response to next anti-cancer therapy of physician's choice (by physician assessment) and duration of response, and sites of disease progression to next anti-cancer therapy following progression on AIE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miracle Mouthwash plus Hydrocortisone | Experimental | Drug: Miracle Mouthwash Plus HydrocortisoneMiracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks. |
| Prednisolone | Active comparator | Drug: PrednisolonePrednisolone oral solution 15 mg/5 ml; swish and expectorate 10cc (10 mL) 4 times per day, every day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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.
Key exclusion criteria (15 listed)
- 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:
- Patient requires chronic treatment with corticosteroids (including inhaled corticosteroids) or other immunosuppressive agents. Topical corticosteroids are allowed;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miracle Mouthwash Plus HydrocortisoneMiracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml) | Drug | Miracle Mouthwash plus Hydrocortisone |
| PrednisoloneAlso: Millipred, Omnipred, Orapred, EconopredPrednisolone oral solution 15 mg/5 ml | Drug | Prednisolone |
Primary outcome
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.
3 secondary outcomes
Incidence of all side effects
Time frame: 64 weeks
Percentage of patients requiring dose interruptions and/or dose reductions of everolimus
Time frame: 64 weeks
Reduction in pain score on questionnaires
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce A. O'Shaughnessy, MD principal investigator
US Oncology Research, McKesson Specialty Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miracle Mouthwash Plus Hydrocortisone and Prednisolone in people with Stomatitis and Oral Mucositis, run by US Oncology Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥ 2 stomatitis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.