RECRUITING

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

Talk to us

Conditions

Colorectal CancerSarcopeniaMyopeniaChemotherapyGeriatric-Oncology

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study

Quick Facts

Study Start:2019-09-23
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03998202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC.
  2. * 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.
  3. * Estimated life expectancy \>= 6 months.
  4. * Patients must be able to comprehend English or Spanish (for questionnaire completion).
  5. * Ability to understand and the willingness to sign a written informed consent document.
  6. * 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.
  1. * Patients enrolled on hospice.
  2. * Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \>= 3 months (12 weeks) prior to this disease disease recurrence and treatment).
  3. * Patients may not be receiving any other investigational agents.
  4. * No untreated brain metastases. Patients with treated brain metastases are eligible.
  5. * Patients on or planned to undergo radiation therapy in near future.

Contacts and Locations

Study Contact

Karen Craver
CONTACT
336-716-0891
NCORP@wakehealth.edu

Principal Investigator

Grant R Williams, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

Beebe South Coastal Health Campus
Frankford, Delaware, 19945
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
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
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
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
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
Mission Cancer and Blood - 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
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood-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
Trinity Regional Medical Center
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
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
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
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
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 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
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
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
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Grant R Williams, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-23
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-09-23
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Colorectal Cancer
  • Myopenia
  • Sarcopenia
  • Chemotherapy
  • Geriatric-Oncology

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Sarcopenia