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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluation of Miracle Mouthwash (MMW) Plus Hydrocortisone and Prednisolone Mouth Rinse as Prophylaxis for Everolimus-Associated Stomatitis

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.

Detailed Summary:

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-st
Sponsor: US Oncology Research

Current Primary Outcome: Incidence of Grade ≥ 2 stomatitis [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence of all side effects [ Time Frame: 64 weeks ]
  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 ]
  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 ]
  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).

Original Secondary Outcome: Same as current

Information By: US Oncology Research

Dates:
Date Received: August 26, 2014
Date Started: September 4, 2014
Date Completion: September 2017
Last Updated: May 18, 2017
Last Verified: May 2017