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Dexamethasone based mouthwash · 1 trial · 1 indication
The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.
| Arm | Type | Description |
|---|---|---|
| Dexamethasone based mouthwash | EXPERIMENTAL | Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations. |
| Name | Type | Description |
|---|---|---|
| Dexamethasone based mouthwash | DRUG | Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone. |
| Everolimus | DRUG | Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations. |
| Exemestane | DRUG | Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations. |
Inclusion Criteria: 1. Adult women \> 18 years of age with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy 2. Histological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER...
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Dexamethasone based mouthwash is being studied to prevent stomatitis, or mouth sores, in post-menopausal women receiving treatment for estrogen-receptor-positive, HER2-negative metastatic or locally advanced breast cancer. It is a steroid-based rinse rather than a cancer-directed therapy, so its purpose is supportive care during breast cancer treatment.
Dexamethasone based mouthwash targets NR3C1, the glucocorticoid receptor, and acts as an agonist at that receptor. Binding and activating NR3C1 produces anti-inflammatory effects in the oral mucosa, which is the basis for studying the rinse as a way to reduce mouth sores in patients undergoing breast cancer treatment.
Novartis AG, which trades under the ticker NVS, is the developer of dexamethasone based mouthwash. The company sponsored the clinical research evaluating the steroid-based rinse in patients with advanced breast cancer.
Dexamethasone based mouthwash is in Phase 2 development. It is investigational and has not been approved by the FDA. The Phase 2 study evaluating it in advanced breast cancer has been completed, and no trials of this asset are currently listed as active.
Dexamethasone based mouthwash was evaluated in one completed Phase 2 trial, NCT02069093. That open-label, uncontrolled study enrolled 92 post-menopausal women aged 18 and older in the United States with estrogen-receptor-positive, HER2-negative metastatic or locally advanced breast cancer, and it assessed the steroid-based mouthwash for stomatitis prevention.
No. The Phase 2 trial of dexamethasone based mouthwash, NCT02069093, was an open-label, uncontrolled study, so it was not randomized and not double blinded. It enrolled 92 post-menopausal women with ER-positive, HER2-negative metastatic or locally advanced breast cancer and has been completed.