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
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|ClinicalTrials.gov Identifier: NCT02015559|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Oral Complications Progesterone Receptor-positive Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer||Drug: mucoadhesive oral wound rinse Other: laboratory biomarker analysis||Phase 2|
I. Evaluate whether use of prophylactic MuGard (mucoadhesive oral wound rinse) in participants being treated with everolimus will reduce the rate of stomatitis.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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.|
|Actual Study Start Date :||October 8, 2014|
|Estimated Primary Completion Date :||April 26, 2019|
|Estimated Study Completion Date :||April 26, 2020|
Experimental: Arm I (mucoadhesive oral wound rinse)
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.
Drug: mucoadhesive oral wound rinse
Other: laboratory biomarker analysis
No Intervention: Arm II (no intervention)
Patients receive no intervention.
- Rate of grades 1-4 stomatitis assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 7 days after completion of treatment ]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.
- Rate of grade 3/4 stomatitis assessed using CTCAE version 4.03 [ Time Frame: Up to 7 days after completion of treatment ]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.
- Rate of everolimus dose adjustment or discontinuation related to stomatitis [ Time Frame: Up to 7 days after completion of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015559
|United States, California|
|Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Parvin Peddi||Jonsson Comprehensive Cancer Center|