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Low Muscle Mass and its Role in Side Effects from Chemotherapy in Older Adults with Colorectal Cancer

Trial Status: Active

This trial studies if myopenia (low muscle mass) plays a role in experiencing side effects from chemotherapy in older patients with colorectal cancer that has spread to other areas of the body (metastatic). Chemotherapy treatments for colorectal cancer can cause side effects such as low blood counts, nausea and vomiting, or mouth sores. Researchers are trying to determine if muscle mass has a role in how bad side effects from chemotherapy can be.

Inclusion Criteria

  • Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC greater than 1 year from completion of treatment for non-metastatic CRC.
  • Planning to undergo 1st line 5-FU based chemotherapy (as monotherapy [as 5-FU alone or capecitabine] or in combination with oxaliplatin and/or irinotecan +/- biologics).
  • 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 body mass index (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 (acceptable if adjuvant chemotherapy completed >= 12 months prior to disease recurrence).
  • Patients may not be receiving any other investigational agents.
  • No untreated brain metastases. Patients with treated brain metastases are eligible.

Delaware

Frankford
Beebe South Coastal Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Newark
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-444-2223

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Chicago
John H Stroger Jr Hospital of Cook County
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-864-5204
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605

Iowa

Cedar Rapids
Oncology Associates at Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 319-363-2690
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921

Kansas

Hays
HaysMed University of Kansas Health System
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 785-623-5774
Salina
Salina Regional Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 785-452-7038
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-588-3671

Louisiana

Shreveport
LSU Health Sciences Center at Shreveport
Status: ACTIVE
Contact: Site Public Contact
Phone: 318-813-1404
Ochsner LSU Health Saint Mary's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 318-813-1404

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-6379
Saint Louis
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569

North Carolina

Clemmons
Wake Forest University at Clemmons
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-716-9259
Hendersonville
Margaret R Pardee Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-696-4716
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Columbus
Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-0227
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118

Pennsylvania

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-459-2901
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-242-7703
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
State College
Geisinger Medical Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251

South Carolina

Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Gaffney
Gibbs Cancer Center-Gaffney
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Greenwood
Self Regional Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-725-4771
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Spartanburg
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Union
MGC Hematology Oncology-Union
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Wisconsin

Eau Claire
HSHS Sacred Heart Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

PRIMARY OBJECTIVE:

I. To examine the association between low muscle mass (myopenia) at diagnosis with cumulative grades 3-5 chemotherapy toxicity in older adults (>= 65 years) with newly diagnosed metastatic colorectal carcinoma (CRC) or newly recognized metastatic recurrence of CRC greater than 1 year from completion of treatment for non-metastatic CRC undergoing fluorouracil (5-fluorouracil [5-FU]) based systemic chemotherapy.

SECONDARY OBJECTIVES:

I. To examine the association between low muscle mass (myopenia) at diagnosis with 1-year overall survival in older adults (>= 65 years) with metastatic CRC.

II. To characterize muscle mass at baseline, and 3 and 6 months after initiation of systemic chemotherapy in older adults with metastatic CRC.

III. Identify distinct trajectories of muscle mass over time in older adults with metastatic CRC and examine the association of trajectories with chemotherapy toxicity and 1 year overall survival.

IV. To examine factors associated with myopenia at baseline and trajectories of muscle loss, including comorbidities, concomitant medications, nutrition, inflammation, physical activity, and age.

V. Examine the role of germline genetic variants in moderating the association between muscle loss and cumulative grades 3-5 chemotherapy toxicity.

VI. To examine factors other than chronologic age that can affect toxicity rates and adverse events as identified using a cancer-specific geriatric assessment.

EXPLORATORY OBJECTIVES:

I. To describe the results of the Was It Worth It (WIWI) questionnaire and Overall Treatment Utility (OTU).

II. To examine the association between low muscle mass at diagnosis and trajectories of muscle loss with functional decline and OTU.

III. To describe the results of the Life-Space Assessment (LSA), and its association with self-reported performance status and muscle measures.

IV. To explore the baseline symptom status of patients on the study and compare symptomatic adverse events reported per the Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) between patients with and without myopenia, and between trajectories of myopenia.

OUTLINE:

Patients perform physical performance (leg strength, walking, and balance) and hand grip tests over 10 minutes, and respond to questionnaires at baseline, 3 months and at 6 months over 29-31 minutes.

After completion of study, patients are followed up for up to 1 year.

Trial Phase Phase NA

Trial Type Ancillary-correlative

Lead Organization
Wake Forest NCORP Research Base

Principal Investigator
Grant R. Williams

  • Primary ID WF-1806
  • Secondary IDs NCI-2019-02514
  • Clinicaltrials.gov ID NCT03998202