Who is sponsoring NCT02229136?

NCT02229136 is sponsored by US Oncology Research.

What condition does NCT02229136 study?

NCT02229136 studies Stomatitis, Oral Mucositis, Neoplasm of the Breast, Malignant Tumor of Breast.

What drugs are being tested in NCT02229136?

Interventions: Miracle Mouthwash Plus Hydrocortisone, Prednisolone.

What is the status of NCT02229136?

NCT02229136 is currently COMPLETED.

Last reviewed 2022-11-29 · How we verify

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

NCT02229136 Phase 2 COMPLETED

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.

Details

Lead sponsor	US Oncology Research
Phase	Phase 2
Status	COMPLETED
Enrolment	104
Start date	2014-09-04
Completion	2022-11

Conditions

Stomatitis
Oral Mucositis
Neoplasm of the Breast
Malignant Tumor of Breast

Interventions

Miracle Mouthwash Plus Hydrocortisone
Prednisolone

Primary outcomes

Incidence of Grade ≥ 2 stomatitis — 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.

Countries

United States