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

NCT03998202 · Wake Forest University Health Sciences
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Official title
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
About this study
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
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
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2019-09-23
Estimated completion: 2026-12-31
Last updated: 2026-01-08
Primary outcomes
  • Number of Chemotherapy Toxicities (Grade 3 - 5) (Up to 6 months (after initiation of chemotherapy))
Sponsor
Wake Forest University Health Sciences · other
With: University of Alabama at Birmingham
Contacts & investigators
ContactKaren Craver · contact · NCORP@wfusm.edu · 336-716-0891
InvestigatorGlenn Lesser, MD · study_chair, WFUSM
All locations (146)
Beebe South Coastal Health CampusRecruiting
Millville, Delaware, United States
Helen F Graham Cancer CenterRecruiting
Newark, Delaware, United States
Medical Oncology Hematology Consultants PARecruiting
Newark, Delaware, United States
Beebe Health CampusRecruiting
Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington HospitalRecruiting
Wilmington, Delaware, United States
MedStar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
John B Amos Cancer CenterRecruiting
Columbus, Georgia, United States
Illinois CancerCare-BloomingtonRecruiting
Bloomington, Illinois, United States
Illinois CancerCare-CantonRecruiting
Canton, Illinois, United States
SIH Cancer InstituteRecruiting
Carterville, Illinois, United States
John H Stroger Jr Hospital of Cook CountyRecruiting
Chicago, Illinois, United States
Carle at The RiverfrontRecruiting
Danville, Illinois, United States
Cancer Care Specialists of Illinois - DecaturRecruiting
Decatur, Illinois, United States
Crossroads Cancer CenterRecruiting
Effingham, Illinois, United States
Illinois CancerCare-GalesburgRecruiting
Galesburg, Illinois, United States
Carle Physician Group - Mattoon/CharlestonRecruiting
Mattoon, Illinois, United States
SSM Health Good SamaritanRecruiting
Mount Vernon, Illinois, United States
Carle BroMenn Medical CenterRecruiting
Normal, Illinois, United States
Carle Cancer Institute NormalRecruiting
Normal, Illinois, United States
Cancer Care Center of O'FallonRecruiting
O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa ClinicRecruiting
Ottawa, Illinois, United States
Illinois CancerCare-PekinRecruiting
Pekin, Illinois, United States
Illinois CancerCare-PeoriaRecruiting
Peoria, Illinois, United States
Illinois CancerCare-PeruRecruiting
Peru, Illinois, United States
Southern Illinois University School of MedicineRecruiting
Springfield, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Carle Cancer CenterRecruiting
Urbana, Illinois, United States
Illinois CancerCare - WashingtonRecruiting
Washington, Illinois, United States
The University of Iowa - AnkenyRecruiting
Ankeny, Iowa, United States
Saint Anthony Regional HospitalRecruiting
Carroll, Iowa, United States
Physicians' Clinic of Iowa PCRecruiting
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical CenterRecruiting
Cedar Rapids, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines ClinicRecruiting
Clive, Iowa, United States
Iowa Methodist Medical CenterRecruiting
Des Moines, Iowa, United States
The University of Iowa-Des MoinesRecruiting
Des Moines, Iowa, United States
Broadlawns Medical CenterRecruiting
Des Moines, Iowa, United States
Mercy Medical Center - Des MoinesRecruiting
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel ClinicRecruiting
Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - Fort DodgeRecruiting
Fort Dodge, Iowa, United States
Saint Joseph Hospital EastWithdrawn
Lexington, Kentucky, United States
Louisiana Hematology Oncology Associates LLCRecruiting
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
MBP Cancer Center - Baton Rouge GeneralRecruiting
Baton Rouge, Louisiana, United States
Terrebonne General Medical CenterRecruiting
Houma, Louisiana, United States
Trinity Health Saint Joseph Mercy Hospital Ann ArborRecruiting
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology-BrightonRecruiting
Brighton, Michigan, United States
Trinity Health Medical Center-BrightonRecruiting
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
Canton, Michigan, United States
Trinity Health Medical Center - CantonRecruiting
Canton, Michigan, United States
Chelsea HospitalRecruiting
Chelsea, Michigan, United States
Trinity Health IHA Hematology Oncology Consultants-Chelsea HospitalRecruiting
Chelsea, Michigan, United States
Cancer Hematology Centers - FlintRecruiting
Flint, Michigan, United States
Genesee Hematology Oncology PCRecruiting
Flint, Michigan, United States
Genesys Hurley Cancer InstituteRecruiting
Flint, Michigan, United States
Marshfield Medical Center DickinsonRecruiting
Iron Mountain, Michigan, United States
Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland HospitalRecruiting
Pontiac, Michigan, United States
Corewell Health Reed City HospitalRecruiting
Reed City, Michigan, United States
University of Michigan Health - WestRecruiting
Wyoming, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology -Ann ArborRecruiting
Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer CenterRecruiting
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical CenterRecruiting
Brainerd, Minnesota, United States
Mercy HospitalRecruiting
Coon Rapids, Minnesota, United States
Essentia Health - Deer River ClinicRecruiting
Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes ClinicRecruiting
Detroit Lakes, Minnesota, United States
Essentia Health Cancer CenterRecruiting
Duluth, Minnesota, United States
Fairview Southdale HospitalRecruiting
Edina, Minnesota, United States
Essentia Health Hibbing ClinicRecruiting
Hibbing, Minnesota, United States
Minnesota Oncology Hematology PA-MaplewoodRecruiting
Maplewood, Minnesota, United States
Saint John's Hospital - HealtheastRecruiting
Maplewood, Minnesota, United States
Abbott-Northwestern HospitalRecruiting
Minneapolis, Minnesota, United States
Health Partners IncWithdrawn
Minneapolis, Minnesota, United States
New Ulm Medical CenterRecruiting
New Ulm, Minnesota, United States
Essentia Health - Park RapidsRecruiting
Park Rapids, Minnesota, United States
Park Nicollet Clinic - Saint Louis ParkRecruiting
Saint Louis Park, Minnesota, United States
Regions HospitalRecruiting
Saint Paul, Minnesota, United States
United HospitalRecruiting
Saint Paul, Minnesota, United States
Essentia Health SandstoneRecruiting
Sandstone, Minnesota, United States
Saint Francis Regional Medical CenterRecruiting
Shakopee, Minnesota, United States
Essentia Health Virginia ClinicRecruiting
Virginia, Minnesota, United States
Rice Memorial HospitalRecruiting
Willmar, Minnesota, United States
Saint Francis Medical CenterRecruiting
Cape Girardeau, Missouri, United States
Parkland Health Center - FarmingtonRecruiting
Farmington, Missouri, United States
Mercy Clinic-Rolla-Cancer and HematologyWithdrawn
Rolla, Missouri, United States
Heartland Regional Medical CenterRecruiting
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial HospitalRecruiting
Sainte Genevieve, Missouri, United States
Mercy Hospital SpringfieldRecruiting
Springfield, Missouri, United States
CoxHealth South HospitalRecruiting
Springfield, Missouri, United States
Missouri Baptist Medical CenterRecruiting
St Louis, Missouri, United States
Missouri Baptist Sullivan HospitalRecruiting
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset HillsRecruiting
Sunset Hills, Missouri, United States
Carolinas Medical Center/Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Atrium Health Pineville/LCI-PinevilleRecruiting
Charlotte, North Carolina, United States
Levine Cancer Institute-SouthParkRecruiting
Charlotte, North Carolina, United States
Atrium Health University City/LCI-UniversityRecruiting
Charlotte, North Carolina, United States
Wake Forest University at ClemmonsRecruiting
Clemmons, North Carolina, United States
Atrium Health Cabarrus/LCI-ConcordRecruiting
Concord, North Carolina, United States
Levine Cancer Institute-GastonRecruiting
Gastonia, North Carolina, United States
Wake Forest Baptist Health - Wilkes Medical CenterRecruiting
Wilkesboro, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical CenterRecruiting
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University ClinicRecruiting
Fargo, North Dakota, United States
Sanford Broadway Medical CenterRecruiting
Fargo, North Dakota, United States
Sanford Roger Maris Cancer CenterRecruiting
Fargo, North Dakota, United States
Adena Regional Medical CenterRecruiting
Chillicothe, Ohio, United States
The Mark H Zangmeister CenterRecruiting
Columbus, Ohio, United States
Armes Family Cancer CenterRecruiting
Findlay, Ohio, United States
Knox Community HospitalRecruiting
Mount Vernon, Ohio, United States
Licking Memorial HospitalRecruiting
Newark, Ohio, United States
Southern Ohio Medical CenterRecruiting
Portsmouth, Ohio, United States
Springfield Regional Cancer CenterRecruiting
Springfield, Ohio, United States
Genesis Healthcare System Cancer Care CenterRecruiting
Zanesville, Ohio, United States
Geisinger Medical CenterRecruiting
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center HazletonRecruiting
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-LewisburgRecruiting
Lewisburg, Pennsylvania, United States
Lewistown HospitalRecruiting
Lewistown, Pennsylvania, United States
Geisinger Cancer Services-PottsvilleRecruiting
Pottsville, Pennsylvania, United States
Community Medical CenterRecruiting
Scranton, Pennsylvania, United States
Geisinger Medical Oncology-SelinsgroveRecruiting
Selinsgrove, Pennsylvania, United States
Geisinger Medical GroupRecruiting
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - SpartanburgRecruiting
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - EasleyRecruiting
Easley, South Carolina, United States
Gibbs Cancer Center-GaffneyRecruiting
Gaffney, South Carolina, United States
Prisma Health Cancer Institute - ButternutRecruiting
Greenville, South Carolina, United States
Prisma Health Cancer Institute - FarisRecruiting
Greenville, South Carolina, United States
Prisma Health Cancer Institute - EastsideRecruiting
Greenville, South Carolina, United States
Self Regional HealthcareWithdrawn
Greenwood, South Carolina, United States
Prisma Health Cancer Institute - GreerRecruiting
Greer, South Carolina, United States
Gibbs Cancer Center-PelhamRecruiting
Greer, South Carolina, United States
Prisma Health Cancer Institute - SenecaRecruiting
Seneca, South Carolina, United States
Spartanburg Medical CenterRecruiting
Spartanburg, South Carolina, United States
MGC Hematology Oncology-UnionRecruiting
Union, South Carolina, United States
Sanford Cancer Center Oncology ClinicRecruiting
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux FallsRecruiting
Sioux Falls, South Dakota, United States
Duluth Clinic AshlandRecruiting
Ashland, Wisconsin, United States
Marshfield Medical Center-EC Cancer CenterRecruiting
Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green BayRecruiting
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
Green Bay, Wisconsin, United States
Marshfield Medical Center-MarshfieldRecruiting
Marshfield, Wisconsin, United States
Marshfield Medical Center - MinocquaRecruiting
Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice LakeRecruiting
Rice Lake, Wisconsin, United States
Essentia Health-Spooner ClinicRecruiting
Spooner, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens PointRecruiting
Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
Sturgeon Bay, Wisconsin, United States
Marshfield Medical Center - WestonRecruiting
Weston, Wisconsin, United States
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer · TrialPath