AzTrials
AzTrials

Advanced Malignant Solid NeoplasmPhase 3NCT04939090

Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients

A Phase 3 study testing Olanzapine, Megestrol Acetate and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm and Anorexia, run by Alliance for Clinical Trials in Oncology at 293 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Olanzapine, Megestrol Acetate and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
293 sitesUnited States
Study dates
3 Jan 2022to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
  • Diagnosis of advanced cancer
  • Patient-reported 2-month weight loss of at least 5 pounds (2.3 kilograms) and/or physician-estimated caloric intake of less than 20 calories/kilogram of body weight per day
  • The patient must perceive loss of appetite and/or weight as a problem; and have an appetite score of 4 or worse on the "Please rate your appetite…." question that requires a patient response on a 0-10 numeric rating scale
  • Not receiving ongoing tube feedings or parenteral nutrition at the time of registration
  • Not currently using systemic adrenal steroids (with the exception of short-term dexamethasone within 3 days of chemotherapy for control of chemotherapy side effects)
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  • No use of androgens, progesterone analogs, or other appetite stimulants within the past month
  • Patient should not have poorly controlled hypertension or congestive heart failure at registration
  • Patient should not have an obstruction of the alimentary canal, malabsorption, or intractable vomiting (defined as vomiting more than 3 times per day over the preceding week)
  • Not currently using olanzapine for another medical condition or had previously used olanzapine for chronic nausea or for any pre-existing psychotic disorder
  • Patient should not have had a previous blood clot at any time in the past
  • No history of poorly controlled diabetes
  • No symptomatic leptomeningeal disease or known brain metastases as these patients may have difficulty taking oral medications
  • No history of hypersensitivity to olanzapine or megestrol acetate
  • No COVID-19 infection in the past that, in the opinion of the treating physician, had left patients with compromised taste, which has not resolved at the time of registration
  • 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 urine or serum pregnancy test done =< 14 days prior to registration is required
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Estimated life expectancy of 3 months or longer
  • Serum creatinine =< 2.0 mg/dL
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN)
  • Fasting glucose < 140 mg/dL
  • Granulocytes > 1000/hpf
  • No treatment with another antipsychotic agent, such as risperidone, quetiapine, clozapine, butyrophenone within 30 days of enrollment
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English or Spanish. Sites seeking to enroll Spanish-speaking patients should have access to Spanish speaking staff on site or through the use of a translation service to be able to conduct the informed consent discussion in Spanish, and to conduct the weekly phone calls

Who cannot join

  • Psychiatric illness which would prevent the patient from giving informed consent
  • Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
  • Patients who cannot swallow oral formulations of the agents
  • Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
  • No presence of a hormone-sensitive tumor, such as breast, endometrial, or prostate cancer (this exclusion criterion is intended to circumvent any confounding antineoplastic effects of megestrol acetate)

Trial locations and contacts

293 sites in 1 country.

293 sites in 1 country

United States293 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

  • Hendrick Medical Center

    Abilene, Texas, 79601

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Baptist Hospitals of Southeast Texas Cancer Center

    Beaumont, Texas, 77701

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • ThedaCare Cancer Care - Berlin

    Berlin, Wisconsin, 54923

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Ballad Health Cancer Care - Bristol

    Bristol, Virginia, 24201

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Northwestern University

    Chicago, Illinois, 60611

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Northwest Cancer Center - Main Campus

    Crown Point, Indiana, 46307

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Halifax Health Medical Center-Centers for Oncology

    Daytona Beach, Florida, 32114

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Epic Care-Dublin

    Dublin, California, 94568

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Levine Cancer Institute - Rutherford

    Forest City, North Carolina, 28043

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Regional Cancer Center-Lee Memorial Health System

    Fort Myers, Florida, 33905

  • Tarrant County Hospital District/JPS Health Network

    Fort Worth, Texas, 76104

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Washington Hospital

    Fremont, California, 94538

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Arizona Center for Cancer Care - Gilbert

    Gilbert, Arizona, 85297

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • East Carolina University

    Greenville, North Carolina, 27834

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Regional Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37604

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Ballad Health Cancer Care - Kingsport

    Kingsport, Tennessee, 37660

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Kaiser Permanente - Largo Medical Center

    Largo, Maryland, 20774

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Kaiser Permanente Lutherville - Timonium Medical Center

    Lutherville, Maryland, 21093

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Atrium Health Union/LCI-Union

    Monroe, North Carolina, 28112

  • The Community Hospital

    Munster, Indiana, 46321

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • ThedaCare Regional Medical Center - Neenah

    Neenah, Wisconsin, 54956

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • ThedaCare Cancer Care - New London

    New London, Wisconsin, 54961

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Piedmont Newnan Hospital

    Newnan, Georgia, 30265

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

  • Ballad Health Cancer Care - Norton

    Norton, Virginia, 24273

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • Halifax Health Center for Oncology - Ormond Beach

    Ormond Beach, Florida, 32174

  • ThedaCare Cancer Care - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Arizona Center for Cancer Care - Phoenix

    Phoenix, Arizona, 85027

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • South Florida Baptist Hospital

    Plant City, Florida, 33563

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Halifax Health Center for Oncology - Port Orange

    Port Orange, Florida, 32127

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Valley Medical Center

    Renton, Washington, 98055

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

  • West Suburban Medical Center

    River Forest, Illinois, 60305

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Levine Cancer Institute-Rock Hill

    Rock Hill, South Carolina, 29732

  • Mease Countryside Hospital

    Safety Harbor, Florida, 34695

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

  • Dominican Santa Cruz Hospital

    Santa Cruz, California, 95065

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Arizona Center for Cancer Care - Osborn

    Scottsdale, Arizona, 85251

  • Arizona Center for Cancer Care - Scottsdale

    Scottsdale, Arizona, 85258

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • ThedaCare Cancer Care - Shawano

    Shawano, Wisconsin, 54166

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint Anthony's Hospital Cancer Care Center

    St. Petersburg, Florida, 33705

  • Bhadresh Nayak MD PC-Sterling Heights

    Sterling Heights, Michigan, 48312

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Piedmont Henry Hospital

    Stockbridge, Georgia, 30281

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

  • Arizona Center for Cancer Care-Surprise

    Surprise, Arizona, 85374

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

  • James J Peters VA Medical Center

    The Bronx, New York, 10468

  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • UM Saint Joseph Medical Center

    Towson, Maryland, 21204

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Northwest Cancer Center - Valparaiso

    Valparaiso, Indiana, 46383

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

  • Epic Care Cyberknife Center

    Walnut Creek, California, 94597

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • Henry Ford Warren Hospital - GLCMS

    Warren, Michigan, 48093

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • Marion L Shepard Cancer Center - ECU Health Beaufort Hospital

    Washington, North Carolina, 27889

  • Kaiser Permanente-Capitol Hill Medical Center

    Washington D.C., District of Columbia, 20002

  • ThedaCare Cancer Care - Waupaca

    Waupaca, Wisconsin, 54981

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • Kaiser Permanente-Caton Hill Medical Center

    Woodbridge, Virginia, 22192

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

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.

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Olanzapine, Megestrol Acetate, Questionnaire Administration
Medical subject headings
Anorexia, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlanzapineDrug

    Given PO

  • Megestrol AcetateDrug

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04939090
Study groupRoleWhat they receive
Arm I (olanzapine)ExperimentalPatients receive olanzapine PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Olanzapine; Other: Questionnaire Administration
Arm II (megestrol acetate)Active comparatorPatients receive megestrol acetate PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Megestrol Acetate; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in appetite

    Will be compared between the two study groups (olanzapine versus megestrol acetate) using a 0-10 numerical rating scale. Will be summarized by mean (standard deviation [SD]) and median (range) by treatment arm. The difference in appetite change from baseline to 4 weeks of treatment between arms will be estimated along with a 95% confidence interval and will be compared using a t-test or Wilcoxon rank-sum test as appropriate.

    Measured: Baseline up to 4 weeks

Secondary outcomes (2)

  1. Proportion of patients who report a 5% or greater weight gain

    The proportion of patients with a 5% or greater weight gain from baseline will be calculated for each arm. The difference in proportion of patients with 5% or greater weight gain between the arms will be estimated along with a 95% confidence interval using a normal approximation of the binomial distribution and will be compared using a Chi-squared test.

    Measured: Baseline up to 4 weeks

  2. Change in well-being status and cachexia/anorexia symptoms

    Responses to the Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS) questionnaire will be scored according to the established algorithm. The total score of the FAACT-A/CS will be summarized weekly and the change from baseline to 4 weeks will be compared between the treatment arms using the same methods described for the primary endpoint.

    Measured: Baseline up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start3 Jan 2022
  3. Primary completion14 Apr 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939090
Sponsor's protocol ID
A222004
Other IDs
NCI-2021-03303, UG1CA189823
Status last verified
Jul 2026
First submitted
17 Jun 2021
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olanzapine, Megestrol Acetate and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm and Anorexia, run by Alliance for Clinical Trials in Oncology at 293 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 293 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in appetite (time frame: Baseline up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04939090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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