Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Purpose
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.
Conditions
- Colorectal Cancer
- Sarcopenia
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Adults 60-74 years | ||
| Adults >= 75 years |
Recruiting Locations
Beebe South Coastal Health Campus
Millville, Delaware 19967
Millville, Delaware 19967
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
Wilmington, Delaware 19801
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Contact:
Site Public Contact
202-444-2223
Site Public Contact
202-444-2223
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204
Site Public Contact
312-864-5204
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Carle Physician Group - Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
SSM Health Good Samaritan
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600
Site Public Contact
618-242-4600
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
The University of Iowa - Ankeny
Ankeny, Iowa 50023
Ankeny, Iowa 50023
Contact:
515-282-2921
515-282-2921
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Contact:
319-297-2900
319-297-2900
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
Clive, Iowa 50325
Contact:
515-241-3305
515-241-3305
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
515-241-6727
515-241-6727
The University of Iowa-Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-282-2921
Site Public Contact
515-282-2921
Broadlawns Medical Center
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
515-282-2200
515-282-2200
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
515-241-3305
515-241-3305
Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
515-574-8302
515-574-8302
Saint Joseph Hospital East
Lexington, Kentucky 40509
Lexington, Kentucky 40509
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
MBP Cancer Center - Baton Rouge General
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Trinity Health IHA Medical Group Hematology Oncology-Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health Medical Center-Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health Medical Center - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Cancer Hematology Centers - Flint
Flint, Michigan 48503
Flint, Michigan 48503
Genesee Hematology Oncology PC
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Marshfield Medical Center Dickinson
Iron Mountain, Michigan 49801
Iron Mountain, Michigan 49801
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Corewell Health Reed City Hospital
Reed City, Michigan 49677
Reed City, Michigan 49677
University of Michigan Health - West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Brainerd, Minnesota 56401
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
Detroit Lakes, Minnesota 56501
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
218-786-3308
218-786-3308
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Health Partners Inc
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
New Ulm Medical Center
New Ulm, Minnesota 56073
New Ulm, Minnesota 56073
Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
Park Rapids, Minnesota 56470
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379
Site Public Contact
573-458-6379
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
417-269-4520
417-269-4520
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Contact:
800-804-9376
800-804-9376
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina 28210
Charlotte, North Carolina 28210
Contact:
980-442-2000
980-442-2000
Levine Cancer Institute-SouthPark
Charlotte, North Carolina 28211
Charlotte, North Carolina 28211
Contact:
980-442-2000
980-442-2000
Atrium Health University City/LCI-University
Charlotte, North Carolina 28262
Charlotte, North Carolina 28262
Contact:
800-804-9376
800-804-9376
Wake Forest University at Clemmons
Clemmons, North Carolina 27012
Clemmons, North Carolina 27012
Contact:
Site Public Contact
888-716-9259
Site Public Contact
888-716-9259
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
Concord, North Carolina 28025
Contact:
800-804-9376
800-804-9376
Levine Cancer Institute-Gaston
Gastonia, North Carolina 28054
Gastonia, North Carolina 28054
Contact:
800-804-9376
800-804-9376
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina 28659
Wilkesboro, North Carolina 28659
Contact:
888-716-9253
888-716-9253
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Adena Regional Medical Center
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
The Mark H Zangmeister Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Southern Ohio Medical Center
Portsmouth, Ohio 45662
Portsmouth, Ohio 45662
Springfield Regional Cancer Center
Springfield, Ohio 45504
Springfield, Ohio 45504
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Zanesville, Ohio 43701
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Lewistown Hospital
Lewistown, Pennsylvania 17044
Lewistown, Pennsylvania 17044
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Pottsville, Pennsylvania 17901
Community Medical Center
Scranton, Pennsylvania 18510
Scranton, Pennsylvania 18510
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania 17870
Selinsgrove, Pennsylvania 17870
Geisinger Medical Group
State College, Pennsylvania 16801
State College, Pennsylvania 16801
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Boiling Springs, South Carolina 29316
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Easley, South Carolina 29640
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
Gaffney, South Carolina 29341
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Self Regional Healthcare
Greenwood, South Carolina 29646
Greenwood, South Carolina 29646
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Greer, South Carolina 29651
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
MGC Hematology Oncology-Union
Union, South Carolina 29379
Union, South Carolina 29379
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
Spooner, Wisconsin 54801
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT03998202
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
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.