Spots Global Cancer Trial Database for Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
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Trial Identification
Brief Title: Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
Official Title: A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia
Study ID: NCT04939090
Study Description
Brief Summary: This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
Detailed Description: The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To determine whether olanzapine leads to greater appetite improvement from baseline in cancer patients suffering from anorexia compared to megestrol acetate using the 0-10 numerical rating scale (NRS). SECONDARY OBJECTIVES: I. To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate. II. To compare change in cachexia/anorexia symptoms with olanzapine compared to megestrol acetate using the Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS) instrument. OUTLINE: Patient are randomized to 1 of 2 arms. ARM I: Patients receive olanzapine orally (PO) once daily (QD) for up to 4 weeks in the absence of consent withdrawal or unacceptable toxicity. ARM II: Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of consent withdrawal or unacceptable toxicity.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States
Arizona Center for Cancer Care-Peoria, Peoria, Arizona, United States
Arizona Center for Cancer Care - Phoenix, Phoenix, Arizona, United States
Arizona Center for Cancer Care - Osborn, Scottsdale, Arizona, United States
Arizona Center for Cancer Care - Scottsdale, Scottsdale, Arizona, United States
Arizona Center for Cancer Care-Surprise, Surprise, Arizona, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States
Epic Care-Dublin, Dublin, California, United States
Epic Care Partners in Cancer Care, Emeryville, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Zuckerberg San Francisco General Hospital, San Francisco, California, United States
Epic Care Cyberknife Center, Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial, Centennial, Colorado, United States
Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose, Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, United States
Grand Valley Oncology, Grand Junction, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, United States
Beebe South Coastal Health Campus, Frankford, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
Morton Plant Hospital, Clearwater, Florida, United States
Regional Cancer Center-Lee Memorial Health System, Fort Myers, Florida, United States
South Florida Baptist Hospital, Plant City, Florida, United States
Mease Countryside Hospital, Safety Harbor, Florida, United States
Saint Anthony's Hospital Cancer Care Center, Saint Petersburg, Florida, United States
Piedmont Hospital, Atlanta, Georgia, United States
Piedmont Fayette Hospital, Fayetteville, Georgia, United States
Piedmont Newnan Hospital, Newnan, Georgia, United States
Piedmont Henry Hospital, Stockbridge, Georgia, United States
Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Mount Sinai Hospital Medical Center, Chicago, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Carle at The Riverfront, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States
Illinois CancerCare-Dixon, Dixon, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient Center, Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center, Grayslake, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Northwestern Medicine Orland Park, Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
West Suburban Medical Center, River Forest, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Illinois CancerCare - Washington, Washington, Illinois, United States
Rush-Copley Healthcare Center, Yorkville, Illinois, United States
Northwest Cancer Center - Main Campus, Crown Point, Indiana, United States
Northwest Oncology LLC, Dyer, Indiana, United States
Northwest Cancer Center - Hobart, Hobart, Indiana, United States
Saint Mary Medical Center, Hobart, Indiana, United States
Saint Catherine Hospital, Indianapolis, Indiana, United States
The Community Hospital, Munster, Indiana, United States
Women's Diagnostic Center - Munster, Munster, Indiana, United States
Northwest Cancer Center - Valparaiso, Valparaiso, Indiana, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic - Ames, Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf, Iowa, United States
McFarland Clinic - Boone, Boone, Iowa, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
McFarland Clinic - Jefferson, Jefferson, Iowa, United States
McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States
Saint Joseph Hospital East, Lexington, Kentucky, United States
UM Upper Chesapeake Medical Center, Bel Air, Maryland, United States
UM Saint Joseph Medical Center, Towson, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States
Trinity Health Medical Center - Brighton, Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States
Trinity Health Medical Center - Canton, Canton, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States
Genesee Hematology Oncology PC, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Huron Gastroenterology PC, Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States
Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center, Brainerd, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic, Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic, Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center, Duluth, Minnesota, United States
Saint Luke's Hospital of Duluth, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Essentia Health - Fosston, Fosston, Minnesota, United States
Essentia Health Hibbing Clinic, Hibbing, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Minneapolis VA Medical Center, Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
Essentia Health - Park Rapids, Park Rapids, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Essentia Health Sandstone, Sandstone, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Sanford Thief River Falls Medical Center, Thief River Falls, Minnesota, United States
Essentia Health Virginia Clinic, Virginia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Sanford Cancer Center Worthington, Worthington, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus, Mississippi, United States
Baptist Cancer Center-Grenada, Grenada, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County, New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
Parkland Health Center - Farmington, Farmington, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Benefis Sletten Cancer Institute, Great Falls, Montana, United States
OptumCare Cancer Care at Seven Hills, Henderson, Nevada, United States
OptumCare Cancer Care at Charleston, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States
Exeter Hospital, Exeter, New Hampshire, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, United States
James J Peters VA Medical Center, Bronx, New York, United States
Glens Falls Hospital, Glens Falls, New York, United States
Queens Hospital Center, Jamaica, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Atrium Health Pineville/LCI-Pineville, Charlotte, North Carolina, United States
Atrium Health University City/LCI-University, Charlotte, North Carolina, United States
Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, United States
Levine Cancer Institute - Rutherford, Forest City, North Carolina, United States
CaroMont Regional Medical Center, Gastonia, North Carolina, United States
Levine Cancer Institute-Gaston, Gastonia, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States
Atrium Health Union/LCI-Union, Monroe, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, United States
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital, Washington, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic, Fargo, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Essentia Health - Jamestown Clinic, Jamestown, North Dakota, United States
Saint Rita's Medical Center, Lima, Ohio, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Community Medical Center, Scranton, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Tidelands Georgetown Memorial Hospital, Georgetown, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Levine Cancer Institute-Rock Hill, Rock Hill, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville, Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States
Baptist Hospitals of Southeast Texas Cancer Center, Beaumont, Texas, United States
UT Southwestern Simmons Cancer Center - RedBird, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Tarrant County Hospital District/JPS Health Network, Fort Worth, Texas, United States
UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States
University of Vermont Medical Center, Burlington, Vermont, United States
Valley Medical Center, Renton, Washington, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
Duluth Clinic Ashland, Ashland, Wisconsin, United States
ThedaCare Cancer Care - Berlin, Berlin, Wisconsin, United States
Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
ThedaCare Regional Medical Center - Neenah, Neenah, Wisconsin, United States
ThedaCare Cancer Care - New London, New London, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Drexel Town Square Health Center, Oak Creek, Wisconsin, United States
ThedaCare Cancer Care - Oshkosh, Oshkosh, Wisconsin, United States
ThedaCare Cancer Care - Shawano, Shawano, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
ThedaCare Cancer Care - Waupaca, Waupaca, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend, Wisconsin, United States
Contact Details
Name: Aminah Jatoi, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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