Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Mouth and Tooth Diseases

Recurrence

Breast Neoplasms

Stomatitis

Breast Diseases

Skin Diseases

Mouth Diseases

Stomatognathic Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Everolimus

Protective Agents

Patients receive mucoadhesive oral wound rinse PO as a gentle swish for 30-60 seconds 3-6 times daily beginning on day 1 of everolimus therapy and continuing for up to 6 months in the absence of unacceptable toxicity.

mucoadhesive oral wound rinse

laboratory biomarker analysis

Parvin Peddi

This randomized phase II trial studies how well mucoadhesive oral wound rinse works in preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed by surgery receiving everolimus. Mucoadhesive oral wound rinse may help prevent symptoms of stomatitis, or mouth sores, in patients receiving everolimus.

PRIMARY OBJECTIVES:

I. Evaluate whether use of prophylactic MuGard (mucoadhesive oral wound rinse) in participants being treated with everolimus will reduce the rate of stomatitis.

SECONDARY OBJECTIVES:

I. Compare symptoms from mouth sores in patients receiving MuGard compared with those receiving best supportive care.

II. Evaluate the rate of everolimus dose adjustment or therapy discontinuation as a result of stomatitis in participants treated with MuGard prophylaxis versus best supportive care.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive mucoadhesive oral wound rinse orally (PO) as a gentle swish for 30-60 seconds 3-6 times daily beginning on day 1 of everolimus therapy and continuing for up to 6 months in the absence of unacceptable toxicity.

ARM II: Patients receive no intervention.

After completion of study treatment, patients are followed up within 7 days.

Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus

Phase II Randomized Trial of Mugard Compared With Best Supportive Care for Prevention and Treatment of Stomatitis in Women With Hormone Receptor Positive Breast Cancer Initiating Treatment With Everolimus-based Endocrine Therapy.

Will be estimated and the 95% confidence interval (CI) will also be obtained. Chi-square test will be used to compare the stomatitis rates between the two study arms.

Will be estimated and the 95% CI will also be obtained. Chi-square test will be used to compare the stomatitis rates between the two study arms.

Translational Research in Oncology

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus	NCT02015559	Estrogen Recept... HER2-negative B... Oral Complicati... Progesterone Re... Recurrent Breas... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast...	mucoadhesive or... laboratory biom...	18 Years -	Jonsson Comprehensive Cancer Center
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus	NCT02015559	Estrogen Recept... HER2-negative B... Oral Complicati... Progesterone Re... Recurrent Breas... Stage IIIB Brea... Stage IIIC Brea... Stage IV Breast...	mucoadhesive or... laboratory biom...	18 Years -	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for mucoadhesive oral wound rinse