Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

NCT ID: NCT03839940

Last Updated: 2025-01-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2022-08-03

Brief Summary

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This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.

Detailed Description

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PRIMARY OBJECTIVES:

I. To determine if the initiation of dexamethasone at the start of everolimus treatment prevents mTOR inhibitor-associated stomatitis (mIAS)-associated pain, compared to the initiation of placebo.

II. To determine if the initiation of dexamethasone at the start of everolimus treatment will be superior compared to the initiation of placebo in terms of the overall severity of mIAS-associated pain.

SECONDARY OBJECTIVES:

I. To utilize the same measurement method that was reported in the SWISH trial: A combination of a patient reported pain scale, data from a normalcy of diet questionnaire, and clinician grading of stomatitis to determine the incidence of \> grade 2 mIAS.

II. To determine if the initiation of dexamethasone at the start of everolimus increases time to development of mouth pain using daily numerical analog scale patient-reported data collection.

III. To assess if quality of life is better when dexamethasone mouth rinse use starts at the same time as everolimus use versus at the time when mouth pain begins.

IV. To investigate if starting dexamethasone mouth rinse concurrent with starting everolimus improves patients' ability to adhere to everolimus therapy.

V. To compare dexamethasone prescription fill rates and timing between patients who received placebo versus study drug at the initiation of everolimus.

Trial Design:

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive everolimus orally (PO) once daily (QD) as standard of care and dexamethasone as mouthwash over 2 minutes 4 times per day (QID) for 8 weeks.

GROUP II: Patients receive everolimus PO QD as standard of care and placebo as mouthwash over 2 minutes QID for 8 weeks.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group I (dexamethasone)

Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Given as mouthwash

Questionnaire

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Everolimus

Intervention Type DRUG

Standard of care

Group II (placebo)

Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Given as mouthwash

Questionnaire

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Everolimus

Intervention Type DRUG

Standard of care

Interventions

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Dexamethasone

Given as mouthwash

Intervention Type DRUG

Placebo

Given as mouthwash

Intervention Type OTHER

Questionnaire

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Everolimus

Standard of care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without an endocrine agent. Patients about to receive everolimus for off label use for any cancer are also eligible.
* Not currently receiving chemotherapy or any other agent known to cause mucositis or stomatitis. Trastuzumab and ovarian function suppression are allowed.
* Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed at least 2 weeks prior to registration.
* Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not have had any stomatitis or mouth pain for at least 7 days prior to registration.
* Patients should not receive any other agent which would be considered treatment for stomatitis or impact the primary endpoint.
* No history of candida infection (thrush) within the last 3 months.
* Not currently being treated with corticosteroids.
* No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although A1C is not needed for all patients, hemoglobin (Hgb)A1C \< 8 is required for everyone with diabetes or suspected diabetes.
* Patients must be able to read and comprehend English. Local translation, including verbal translation of professionals (PROs) is not permitted.
* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Ruddy, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Kingman Regional Medical Center

Kingman, Arizona, United States

Site Status

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Epic Care-Dublin

Dublin, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute

Oakland, California, United States

Site Status

Epic Care Cyberknife Center

Walnut Creek, California, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Site Status

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States

Site Status

Kootenai Cancer Center

Post Falls, Idaho, United States

Site Status

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status

SIH Cancer Institute

Carterville, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

Carle on Vermilion

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Trinity Regional Medical Center

Fort Dodge, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Ochsner LSU Health Monroe Medical Center

Monroe, Louisiana, United States

Site Status

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Site Status

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Site Status

Mercy Medical Center

Springfield, Massachusetts, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, United States

Site Status

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

Caro Cancer Center

Caro, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, United States

Site Status

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Site Status

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, United States

Site Status

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Site Status

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

Academic Hematology Oncology Specialists

Grosse Pointe Woods, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Hope Cancer Clinic

Livonia, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status

Mercy Health Mercy Campus

Muskegon, Michigan, United States

Site Status

Lakeland Hospital Niles

Niles, Michigan, United States

Site Status

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Site Status

21st Century Oncology-Pontiac

Pontiac, Michigan, United States

Site Status

Hope Cancer Center

Pontiac, Michigan, United States

Site Status

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Huron Medical Center PC

Port Huron, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Spectrum Health Reed City Hospital

Reed City, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, United States

Site Status

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

Site Status

Ascension Saint Joseph Hospital

Tawas City, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Advanced Breast Care Center PLLC

Warren, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status

Macomb Hematology Oncology PC

Warren, Michigan, United States

Site Status

Michigan Breast Specialists-Warren

Warren, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status

Metro Health Hospital

Wyoming, Michigan, United States

Site Status

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Cambridge Medical Center

Cambridge, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status

Fairview Northland Medical Center

Princeton, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Sanford Cancer Center Worthington

Worthington, Minnesota, United States

Site Status

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Site Status

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, United States

Site Status

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status

Capital Region Southwest Campus

Jefferson City, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital South

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, United States

Site Status

Mercy Hospital Washington

Washington, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Nebraska Hematology and Oncology

Lincoln, Nebraska, United States

Site Status

Southeast Nebraska Cancer Center - 68th Street Place

Lincoln, Nebraska, United States

Site Status

Faith Regional Health Services Carson Cancer Center

Norfolk, Nebraska, United States

Site Status

Great Plains Health Callahan Cancer Center

North Platte, Nebraska, United States

Site Status

Nebraska Cancer Specialists - Omaha

Omaha, Nebraska, United States

Site Status

Oncology Hematology West PC

Omaha, Nebraska, United States

Site Status

Regional West Medical Center Cancer Center

Scottsbluff, Nebraska, United States

Site Status

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Site Status

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Site Status

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status

21st Century Oncology-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Site Status

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Pecos

Las Vegas, Nevada, United States

Site Status

Desert West Surgery

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Oakey

Las Vegas, Nevada, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Central

Las Vegas, Nevada, United States

Site Status

21st Century Oncology

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Las Vegas Prostate Cancer Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Sunset

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

Ann M Wierman MD LTD

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Cathedral Rock

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Smoke Ranch

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Southwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

University Cancer Center

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Site Status

Radiation Oncology Associates

Reno, Nevada, United States

Site Status

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Site Status

Virtua Samson Cancer Center

Moorestown, New Jersey, United States

Site Status

Virtua Memorial

Mount Holly, New Jersey, United States

Site Status

Virtua Voorhees

Voorhees Township, New Jersey, United States

Site Status

Hematology Oncology Associates of Central New York-Auburn

Auburn, New York, United States

Site Status

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, United States

Site Status

Hematology Oncology Associates of Central New York-Onondaga Hill

Syracuse, New York, United States

Site Status

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford South University Medical Center

Fargo, North Dakota, United States

Site Status

Southpointe-Sanford Medical Center Fargo

Fargo, North Dakota, United States

Site Status

Sanford Medical Center Fargo

Fargo, North Dakota, United States

Site Status

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Altru Cancer Center

Grand Forks, North Dakota, United States

Site Status

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Mount Carmel East Hospital

Columbus, Ohio, United States

Site Status

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Dublin Methodist Hospital

Dublin, Ohio, United States

Site Status

Central Ohio Breast and Endocrine Surgery

Gahanna, Ohio, United States

Site Status

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

OhioHealth Marion General Hospital

Marion, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Newark Radiation Oncology

Newark, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

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Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

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Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, United States

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Legacy Mount Hood Medical Center

Gresham, Oregon, United States

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Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, United States

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Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

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Legacy Meridian Park Hospital

Tualatin, Oregon, United States

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Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

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Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

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Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

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Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

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Self Regional Healthcare

Greenwood, South Carolina, United States

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Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

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Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

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Overlake Medical Center

Bellevue, Washington, United States

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Valley Medical Center

Renton, Washington, United States

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Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, United States

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Legacy Salmon Creek Hospital

Vancouver, Washington, United States

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Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, United States

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Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

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Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Site Status

Mayo Clinic Health System Eau Claire Hospital-Luther Campus

Eau Claire, Wisconsin, United States

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Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

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Marshfield Clinic - Ladysmith Center

Ladysmith, Wisconsin, United States

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Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

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Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

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Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

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Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

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Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, United States

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Marshfield Clinic-Wausau Center

Wausau, Wisconsin, United States

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Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Countries

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United States

References

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Ruddy KJ, Zahrieh D, He J, Waechter B, Holleran JL, Lewis LD, Chow S, Beumer J, Weiss M, Trikalinos N, Faller B, Lustberg M, Rugo HS, Loprinzi C. Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701). Semin Oncol. 2023 Feb-Apr;50(1-2):7-10. doi: 10.1053/j.seminoncol.2023.01.001. Epub 2023 Jan 17.

Reference Type DERIVED
PMID: 36693773 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

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Document Type: Individual Participant Data Set

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View Document

Other Identifiers

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NCI-2018-02648

Identifier Type: REGISTRY

Identifier Source: secondary_id

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A221701

Identifier Type: -

Identifier Source: org_study_id

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