NCT04939090

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P25-P50 for phase_3

Timeline
20mo left

Started Jan 2022

Longer than P75 for phase_3

Geographic Reach
1 country

293 active sites

Status
active not recruiting

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

Study Progress72%
Jan 2022Dec 2027

First Submitted

Initial submission to the registry

June 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 3, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.2 years

First QC Date

June 17, 2021

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

    Baseline up to 4 weeks

Secondary Outcomes (2)

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

    Baseline up to 4 weeks

  • Change in well-being status and cachexia/anorexia symptoms

    Baseline up to 4 weeks

Study Arms (2)

Arm I (olanzapine)

EXPERIMENTAL

Patients receive olanzapine PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: OlanzapineOther: Questionnaire Administration

Arm II (megestrol acetate)

ACTIVE COMPARATOR

Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Megestrol AcetateOther: Questionnaire Administration

Interventions

Ancillary studies

Arm I (olanzapine)Arm II (megestrol acetate)

Given PO

Arm I (olanzapine)

Given PO

Arm II (megestrol acetate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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
  • +10 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (293)

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, 85297, United States

Location

CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, 85381, United States

Location

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, 85027, United States

Location

Arizona Center for Cancer Care - Osborn

Scottsdale, Arizona, 85251, United States

Location

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, 85258, United States

Location

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, 85374, United States

Location

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

Epic Care-Dublin

Dublin, California, 94568, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

Washington Hospital

Fremont, California, 94538, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Dominican Santa Cruz Hospital

Santa Cruz, California, 95065, United States

Location

Epic Care Cyberknife Center

Walnut Creek, California, 94597, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, 80112, United States

Location

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, 80220, United States

Location

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, 80113, United States

Location

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, 80113, United States

Location

Grand Valley Oncology

Grand Junction, Colorado, 81505, United States

Location

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, 80228, United States

Location

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, 80260, United States

Location

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

Location

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

Location

Kaiser Permanente-Capitol Hill Medical Center

Washington D.C., District of Columbia, 20002, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Halifax Health Medical Center-Centers for Oncology

Daytona Beach, Florida, 32114, United States

Location

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, 33905, United States

Location

Halifax Health Center for Oncology - Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

South Florida Baptist Hospital

Plant City, Florida, 33563, United States

Location

Halifax Health Center for Oncology - Port Orange

Port Orange, Florida, 32127, United States

Location

Mease Countryside Hospital

Safety Harbor, Florida, 34695, United States

Location

Saint Anthony's Hospital Cancer Care Center

St. Petersburg, Florida, 33705, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Piedmont Newnan Hospital

Newnan, Georgia, 30265, United States

Location

Piedmont Henry Hospital

Stockbridge, Georgia, 30281, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Castle Medical Center

Kailua, Hawaii, 96734, United States

Location

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

Location

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

Location

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

Location

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

Location

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Mount Sinai Hospital Medical Center

Chicago, Illinois, 60608, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

Location

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

Location

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

Location

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Carle BroMenn Medical Center

Normal, Illinois, 61761, United States

Location

Carle Cancer Institute Normal

Normal, Illinois, 61761, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523, United States

Location

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

West Suburban Medical Center

River Forest, Illinois, 60305, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

Location

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

Location

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States

Location

Northwest Cancer Center - Main Campus

Crown Point, Indiana, 46307, United States

Location

Northwest Oncology LLC

Dyer, Indiana, 46311, United States

Location

Northwest Cancer Center - Hobart

Hobart, Indiana, 46342, United States

Location

Saint Mary Medical Center

Hobart, Indiana, 46342, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Saint Catherine Hospital

Indianapolis, Indiana, 46312, United States

Location

The Community Hospital

Munster, Indiana, 46321, United States

Location

Women's Diagnostic Center - Munster

Munster, Indiana, 46321, United States

Location

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722, United States

Location

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

Location

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

Location

Saint Joseph Hospital East

Lexington, Kentucky, 40509, United States

Location

Kaiser Permanente-Woodlawn Medical Center

Baltimore, Maryland, 21244, United States

Location

UM Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States

Location

Kaiser Permanente-Gaithersburg Medical Center

Gaithersburg, Maryland, 20879, United States

Location

Kaiser Permanente - Largo Medical Center

Largo, Maryland, 20774, United States

Location

Kaiser Permanente Lutherville - Timonium Medical Center

Lutherville, Maryland, 21093, United States

Location

UM Saint Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

Location

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

Location

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

Location

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

Location

Chelsea Hospital

Chelsea, Michigan, 48118, United States

Location

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

Location

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Henry Ford River District Hospital

East China Township, Michigan, 48054, United States

Location

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

Location

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, 48236, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

Location

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, 48312, United States

Location

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764, United States

Location

Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States

Location

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093, United States

Location

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

Location

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

Location

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

Location

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Essentia Health - Fosston

Fosston, Minnesota, 56542, United States

Location

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

Location

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States

Location

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Sanford Cancer Center Worthington

Worthington, Minnesota, 56187, United States

Location

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705, United States

Location

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901, United States

Location

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652, United States

Location

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Saint Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States

Location

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

Location

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, 89144, United States

Location

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148, United States

Location

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States

Location

Exeter Hospital

Exeter, New Hampshire, 03833, United States

Location

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Memorial Medical Center-Las Cruces

Las Cruces, New Mexico, 88011, United States

Location

Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210, United States

Location

Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262, United States

Location

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328, United States

Location

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

Location

Levine Cancer Institute - Rutherford

Forest City, North Carolina, 28043, United States

Location

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

Location

Levine Cancer Institute-Gaston

Gastonia, North Carolina, 28054, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Atrium Health Union/LCI-Union

Monroe, North Carolina, 28112, United States

Location

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Marion L Shepard Cancer Center - ECU Health Beaufort Hospital

Washington, North Carolina, 27889, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, 58401, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Saint Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201, United States

Location

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

Location

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, 17901, United States

Location

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Community Medical Center

Scranton, Pennsylvania, 18510, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, 29440, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Bristol Regional Medical Center

Bristol, Tennessee, 37620, United States

Location

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017, United States

Location

Regional Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37604, United States

Location

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, 37660, United States

Location

Wellmont Holston Valley Hospital and Medical Center

Kingsport, Tennessee, 37660, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

Hendrick Medical Center

Abilene, Texas, 79601, United States

Location

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Baptist Hospitals of Southeast Texas Cancer Center

Beaumont, Texas, 77701, United States

Location

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Tarrant County Hospital District/JPS Health Network

Fort Worth, Texas, 76104, United States

Location

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States

Location

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States

Location

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

Location

Ballad Health Cancer Care - Bristol

Bristol, Virginia, 24201, United States

Location

Kaiser Permanente Tysons Corner Medical Center

McLean, Virginia, 22102, United States

Location

Ballad Health Cancer Care - Norton

Norton, Virginia, 24273, United States

Location

Kaiser Permanente-Caton Hill Medical Center

Woodbridge, Virginia, 22192, United States

Location

Valley Medical Center

Renton, Washington, 98055, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States

Location

ThedaCare Cancer Care - Berlin

Berlin, Wisconsin, 54923, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, 54956, United States

Location

ThedaCare Cancer Care - New London

New London, Wisconsin, 54961, United States

Location

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States

Location

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States

Location

ThedaCare Cancer Care - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

ThedaCare Cancer Care - Shawano

Shawano, Wisconsin, 54166, United States

Location

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

ThedaCare Cancer Care - Waupaca

Waupaca, Wisconsin, 54981, United States

Location

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

AnorexiaHematologic Neoplasms

Interventions

OlanzapineMegestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Aminah Jatoi, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 25, 2021

Study Start

January 3, 2022

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations