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NCT03998202Recruiting

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer

Wake Forest University Health Sciences

Start Date

9/23/2019

Completion Date

12/31/2026

Summary

This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.

Detailed Description

This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.

Eligibility Criteria

Age Range: 60 years to No maximum

Inclusion Criteria: * Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC. * Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable. * Estimated life expectancy \>= 6 months. * Patients must be able to comprehend English or Spanish (for questionnaire completion). * Ability to understand and the willingness to sign a written informed consent document. * Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- \> 10%) body weight change in the previous 12 months are eligible for this study. Exclusion Criteria: * Patients enrolled on hospice. * Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \>= 3 months (12 weeks) prior to this disease disease recurrence and treatment). * Patients may not be receiving any other investigational agents. * No untreated brain metastases. Patients with treated brain metastases are eligible. * Patients on or planned to undergo radiation therapy in near future.

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Conditions

Colorectal CancerSarcopenia

Locations

Beebe South Coastal Health Campus

Millville, Delaware 19967

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Beebe Health Campus

Rehoboth Beach, Delaware 19971

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware 19801

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

John B Amos Cancer Center

Columbus, Georgia 31904

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois 61704

United States

Illinois CancerCare-Canton

Canton, Illinois 61520

United States

SIH Cancer Institute

Carterville, Illinois 62918

United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois 60612

United States

Carle at The Riverfront

Danville, Illinois 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois 62526

United States

Crossroads Cancer Center

Effingham, Illinois 62401

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois 61401

United States

Carle Physician Group - Mattoon/Charleston

Mattoon, Illinois 61938

United States

SSM Health Good Samaritan

Mount Vernon, Illinois 62864

United States

Carle BroMenn Medical Center

Normal, Illinois 61761

United States

Carle Cancer Institute Normal

Normal, Illinois 61761

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

Illinois CancerCare-Peru

Peru, Illinois 61354

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Springfield Clinic

Springfield, Illinois 62702

United States

Carle Cancer Center

Urbana, Illinois 61801

United States

Illinois CancerCare - Washington

Washington, Illinois 61571

United States

The University of Iowa - Ankeny

Ankeny, Iowa 50023

United States

Saint Anthony Regional Hospital

Carroll, Iowa 51401

United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa 52402

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa 52403

United States

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

Clive, Iowa 50325

United States

Iowa Methodist Medical Center

Des Moines, Iowa 50309

United States

The University of Iowa-Des Moines

Des Moines, Iowa 50309

United States

Broadlawns Medical Center

Des Moines, Iowa 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa 50314

United States

UI Healthcare Mission Cancer and Blood - Fort Dodge

Fort Dodge, Iowa 50501

United States

Saint Joseph Hospital East

Lexington, Kentucky 40509

United States

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana 70809

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809

United States

MBP Cancer Center - Baton Rouge General

Baton Rouge, Louisiana 70809

United States

Terrebonne General Medical Center

Houma, Louisiana 70360

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan 48106

United States

Trinity Health IHA Medical Group Hematology Oncology-Brighton

Brighton, Michigan 48114

United States

Trinity Health Medical Center-Brighton

Brighton, Michigan 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan 48188

United States

Chelsea Hospital

Chelsea, Michigan 48118

United States

Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital

Chelsea, Michigan 48118

United States

Cancer Hematology Centers - Flint

Flint, Michigan 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan 48503

United States

Marshfield Medical Center Dickinson

Iron Mountain, Michigan 49801

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan 48154

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan 48341

United States

Corewell Health Reed City Hospital

Reed City, Michigan 49677

United States

University of Michigan Health - West

Wyoming, Michigan 49519

United States

Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor

Ypsilanti, Michigan 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota 56601

United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota 56401

United States

Mercy Hospital

Coon Rapids, Minnesota 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota 56636

United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota 56501

United States

Essentia Health Cancer Center

Duluth, Minnesota 55805

United States

Fairview Southdale Hospital

Edina, Minnesota 55435

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota 55746

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

Health Partners Inc

Minneapolis, Minnesota 55454

United States

New Ulm Medical Center

New Ulm, Minnesota 56073

United States

Essentia Health - Park Rapids

Park Rapids, Minnesota 56470

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

Essentia Health Sandstone

Sandstone, Minnesota 55072

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota 55379

United States

Essentia Health Virginia Clinic

Virginia, Minnesota 55792

United States

Rice Memorial Hospital

Willmar, Minnesota 56201

United States

Saint Francis Medical Center

Cape Girardeau, Missouri 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri 63640

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

Missouri Baptist Medical Center

St Louis, Missouri 63131

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri 63127

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina 28203

United States

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina 28210

United States

Levine Cancer Institute-SouthPark

Charlotte, North Carolina 28211

United States

Atrium Health University City/LCI-University

Charlotte, North Carolina 28262

United States

Wake Forest University at Clemmons

Clemmons, North Carolina 27012

United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina 28025

United States

Levine Cancer Institute-Gaston

Gastonia, North Carolina 28054

United States

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina 28659

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota 58501

United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota 58103

United States

Sanford Broadway Medical Center

Fargo, North Dakota 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota 58122

United States

Adena Regional Medical Center

Chillicothe, Ohio 45601

United States

The Mark H Zangmeister Center

Columbus, Ohio 43219

United States

Armes Family Cancer Center

Findlay, Ohio 45840

United States

Knox Community Hospital

Mount Vernon, Ohio 43050

United States

Licking Memorial Hospital

Newark, Ohio 43055

United States

Southern Ohio Medical Center

Portsmouth, Ohio 45662

United States

Springfield Regional Cancer Center

Springfield, Ohio 45504

United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio 43701

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania 18201

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania 17837

United States

Lewistown Hospital

Lewistown, Pennsylvania 17044

United States

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania 17901

United States

Community Medical Center

Scranton, Pennsylvania 18510

United States

Geisinger Medical Oncology-Selinsgrove

Selinsgrove, Pennsylvania 17870

United States

Geisinger Medical Group

State College, Pennsylvania 16801

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania 18711

United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina 29316

United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina 29640

United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina 29341

United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina 29605

United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina 29605

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina 29615

United States

Self Regional Healthcare

Greenwood, South Carolina 29646

United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina 29650

United States

Gibbs Cancer Center-Pelham

Greer, South Carolina 29651

United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina 29672

United States

Spartanburg Medical Center

Spartanburg, South Carolina 29303

United States

MGC Hematology Oncology-Union

Union, South Carolina 29379

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

Duluth Clinic Ashland

Ashland, Wisconsin 54806

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin 54701

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin 54303

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin 54449

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin 54548

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin 54868

United States

Essentia Health-Spooner Clinic

Spooner, Wisconsin 54801

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin 54482

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin 54235-1495

United States

Marshfield Medical Center - Weston

Weston, Wisconsin 54476

United States