Table of Contents

• What is Dexamethasone?
• Clinical Trial Overview
• How the Mouthwash is Used
• Target Patient Group
• Other Medications in the Study
• Study Outcomes

What is Dexamethasone?

Dexamethasone is a type of steroid medication that has anti-inflammatory properties. In this clinical trial, it is being studied in the form of a mouthwash to prevent a condition called stomatitis^[1]. Stomatitis is an inflammation of the mouth and lips that can occur as a side effect of certain cancer treatments.

Clinical Trial Overview

The clinical trial described here is an open-label, Phase II study focusing on the prevention of stomatitis in post-menopausal women with advanced breast cancer^[1]. The study aims to evaluate the effectiveness of a dexamethasone-based mouthwash in preventing mouth sores and inflammation that can occur during cancer treatment.

How the Mouthwash is Used

The dexamethasone mouthwash used in this study has the following characteristics and usage instructions^[1]:

• It is an alcohol-free oral solution
• The concentration is 0.5 milligrams of dexamethasone per 5mL of solution
• Patients are instructed to use 10mL of the mouthwash
• The mouthwash should be swished in the mouth for 2 minutes and then spit out
• This process is repeated 4 times daily
• The treatment duration in the study is 8 weeks
• After using the mouthwash, patients should not eat or drink anything for one hour

Target Patient Group

This study focuses on a specific group of breast cancer patients^[1]:

• Post-menopausal women
• Diagnosed with advanced breast cancer (either metastatic or locally advanced)
• Their cancer is estrogen-receptor positive (ER+), which means the cancer cells grow in response to the hormone estrogen
• Their cancer is HER2-negative, meaning it doesn’t have high levels of a protein called HER2 on the cancer cells

Other Medications in the Study

In addition to the dexamethasone mouthwash, patients in this study also receive two other medications^[1]:

1. Everolimus: A 10 mg dose, taken orally. Everolimus is a type of targeted therapy that can help slow down the growth of cancer cells.
2. Exemestane: A 25 mg dose, taken orally. Exemestane is a type of hormone therapy that lowers estrogen levels in the body, which can slow or stop the growth of ER+ breast cancers.

These medications are prescribed according to local regulations and are part of the standard treatment for this type of breast cancer.

Study Outcomes

The study aims to measure several outcomes to determine the effectiveness of the dexamethasone mouthwash^[1]:

1. Incidence of stomatitis: The main goal is to see how many patients develop grade 2 or higher stomatitis. Stomatitis is graded on a scale from 1 to 4, with higher numbers indicating more severe symptoms.
2. Time to resolution: If patients do develop stomatitis, how long does it take for the condition to improve from grade 2 or higher to grade 1 or less?
3. Mouthwash usage: The study will track how many times per day patients actually use the mouthwash.
4. Overall stomatitis rates: The number of patients who develop any grade of stomatitis will be recorded.
5. Medication dosing: The study will look at whether patients are able to take their full doses of everolimus and exemestane when using the mouthwash.
6. Blood levels: The concentration of everolimus and exemestane in patients’ blood will be measured to see if the mouthwash affects how the body processes these drugs.

By studying these outcomes, researchers hope to determine if the dexamethasone mouthwash can effectively prevent or reduce the severity of stomatitis in breast cancer patients undergoing treatment with everolimus and exemestane.