Study Stopped
Severe lack of accrual
Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
MIST
Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches: MIST (My Individualized Stomatitis Treatment)
3 other identifiers
interventional
39
1 country
319
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2019
Typical duration for phase_3
319 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2021
CompletedResults Posted
Study results publicly available
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedJanuary 29, 2025
January 1, 2025
1.6 years
February 6, 2019
March 3, 2022
January 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale
The numerical analogue mouth pain score (NAMPS) is a single item measured on a 0 to 10 scale, with 0 corresponding to "No pain" and 10 corresponding to "Pain as bad as it can be." Will compare the incidence rate of any mouth pain (i.e., any score greater than 0) as assessed by the NAMPS between the prevention versus early treatment approaches using a Chi-square test.
Up to 8 weeks
Severity of Mouth Pain Scores
Average Area Under the Curve per assessment (aAUCpa) of mouth pain scores as measured by NAMPS will be computed for each patient to summarize the sequence of numerical analogue mouth pain scores over the eight week study period. Scores are reported on a 0-100 scale, where 100 = better outcome QOL (i.e. less pain). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the end of the treatment at 8 weeks post-treatment-initiation and will be compared between the two treatment arms.
Up to 8 weeks
Secondary Outcomes (15)
Incidence of Grade > 2 mIAS as Measured by the SWISH Trial
Up to 8 weeks
Incidence of Mouth Pain
Up to 8 weeks
Time to Development of Mouth Pain
Up to 8 weeks
Quality of Life Assessed by Linear Analogue Self-Assessment
Up to 8 weeks
Mouth/Throat Sore Level of Activity Interference With Daily Activities
Up to 8 weeks
- +10 more secondary outcomes
Other Outcomes (6)
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Sex
Up to 8 weeks
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Race
Up to 8 weeks
Incidence Rate of the mTOR Inhibitor-associated Stomatitis (mIAS)-Related Pain Based on Daily Self-reports Via the Numerical Analogue Scale by Ethnicity.
Up to 8 weeks
- +3 more other outcomes
Study Arms (2)
Group I (dexamethasone)
EXPERIMENTALPatients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
Group II (placebo)
PLACEBO COMPARATORPatients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (319)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Epic Care-Dublin
Dublin, California, 94568, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Epic Care Partners in Cancer Care
Emeryville, California, 94608, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, 83686, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Ochsner LSU Health Monroe Medical Center
Monroe, Louisiana, 71202, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
Mercy Medical Center
Springfield, Massachusetts, 01104, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, 48114, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114, United States
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, 48188, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, 48118, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan, 48054, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Hope Cancer Clinic
Livonia, Michigan, 48154, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044, United States
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Lakeland Hospital Niles
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
21st Century Oncology-Pontiac
Pontiac, Michigan, 48341, United States
Hope Cancer Center
Pontiac, Michigan, 48341, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Huron Medical Center PC
Port Huron, Michigan, 48060, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, 48309, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
Michigan Breast Specialists-Warren
Warren, Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, 68506, United States
Southeast Nebraska Cancer Center - 68th Street Place
Lincoln, Nebraska, 68516, United States
Faith Regional Health Services Carson Cancer Center
Norfolk, Nebraska, 68701, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, 69101, United States
Nebraska Cancer Specialists - Omaha
Omaha, Nebraska, 68124, United States
Oncology Hematology West PC
Omaha, Nebraska, 68130, United States
Regional West Medical Center Cancer Center
Scottsbluff, Nebraska, 69361, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
21st Century Oncology-Henderson
Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Oakey
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
21st Century Oncology
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada, 89128, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
21st Century Oncology-Fort Apache
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Virtua Samson Cancer Center
Moorestown, New Jersey, 08057, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse, New York, 13215, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford South University Medical Center
Fargo, North Dakota, 58103, United States
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103, United States
Sanford Medical Center Fargo
Fargo, North Dakota, 58104, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
Valley Medical Center
Renton, Washington, 98055, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire, Wisconsin, 54703, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
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.
PMID: 36693773DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kathryn J. Ruddy
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Kathryn Ruddy, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2019
First Posted
February 15, 2019
Study Start
June 3, 2019
Primary Completion
January 8, 2021
Study Completion
August 3, 2022
Last Updated
January 29, 2025
Results First Posted
August 1, 2022
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive