Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
- Conditions
- Colorectal CancerSarcopenia
- Registration Number
- NCT03998202
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Chemotherapy Toxicities (Grade 3 - 5) Up to 6 months (after initiation of chemotherapy) Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
- Secondary Outcome Measures
Name Time Method Overall Survival 1 year Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
Trial Locations
- Locations (136)
SSM Health Good Samaritan
🇺🇸Mount Vernon, Illinois, United States
Beebe South Coastal Health Campus
🇺🇸Frankford, Delaware, United States
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
🇺🇸Newark, Delaware, United States
Beebe Health Campus
🇺🇸Rehoboth Beach, Delaware, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Illinois CancerCare-Bloomington
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Canton
🇺🇸Canton, Illinois, United States
John H Stroger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Carle at The Riverfront
🇺🇸Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
🇺🇸Decatur, Illinois, United States
Crossroads Cancer Center
🇺🇸Effingham, Illinois, United States
Illinois CancerCare-Galesburg
🇺🇸Galesburg, Illinois, United States
Carle Physician Group - Mattoon/Charleston
🇺🇸Mattoon, Illinois, United States
Cancer Care Center of O'Fallon
🇺🇸O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare-Pekin
🇺🇸Pekin, Illinois, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Illinois CancerCare-Peru
🇺🇸Peru, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Illinois CancerCare - Washington
🇺🇸Washington, Illinois, United States
Mission Cancer and Blood - Ankeny
🇺🇸Ankeny, Iowa, United States
Saint Anthony Regional Hospital
🇺🇸Carroll, Iowa, United States
Physicians' Clinic of Iowa PC
🇺🇸Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Mission Cancer and Blood-Des Moines
🇺🇸Des Moines, Iowa, United States
Broadlawns Medical Center
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Trinity Regional Medical Center
🇺🇸Fort Dodge, Iowa, United States
Saint Joseph Hospital East
🇺🇸Lexington, Kentucky, United States
Louisiana Hematology Oncology Associates LLC
🇺🇸Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
MBP Cancer Center - Baton Rouge General
🇺🇸Baton Rouge, Louisiana, United States
Terrebonne General Medical Center
🇺🇸Houma, Louisiana, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology-Brighton
🇺🇸Brighton, Michigan, United States
Trinity Health Medical Center-Brighton
🇺🇸Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
🇺🇸Canton, Michigan, United States
Trinity Health Medical Center - Canton
🇺🇸Canton, Michigan, United States
Chelsea Hospital
🇺🇸Chelsea, Michigan, United States
Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital
🇺🇸Chelsea, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center
🇺🇸Flint, Michigan, United States
Genesee Hematology Oncology PC
🇺🇸Flint, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
🇺🇸Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
🇺🇸Pontiac, Michigan, United States
Corewell Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
University of Michigan Health - West
🇺🇸Wyoming, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor
🇺🇸Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center
🇺🇸Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
🇺🇸Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
🇺🇸Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
🇺🇸Duluth, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Essentia Health Hibbing Clinic
🇺🇸Hibbing, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Health Partners Inc
🇺🇸Minneapolis, Minnesota, United States
New Ulm Medical Center
🇺🇸New Ulm, Minnesota, United States
Essentia Health - Park Rapids
🇺🇸Park Rapids, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Essentia Health Sandstone
🇺🇸Sandstone, Minnesota, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States
Essentia Health Virginia Clinic
🇺🇸Virginia, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington
🇺🇸Farmington, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital
🇺🇸Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Missouri Baptist Sullivan Hospital
🇺🇸Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
🇺🇸Sunset Hills, Missouri, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Atrium Health Pineville/LCI-Pineville
🇺🇸Charlotte, North Carolina, United States
Levine Cancer Institute-SouthPark
🇺🇸Charlotte, North Carolina, United States
Atrium Health University City/LCI-University
🇺🇸Charlotte, North Carolina, United States
Wake Forest University at Clemmons
🇺🇸Clemmons, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord
🇺🇸Concord, North Carolina, United States
Levine Cancer Institute-Gaston
🇺🇸Gastonia, North Carolina, United States
Wake Forest Baptist Health - Wilkes Medical Center
🇺🇸Wilkesboro, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
🇺🇸Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
🇺🇸Fargo, North Dakota, United States
Sanford Broadway Medical Center
🇺🇸Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
The Mark H Zangmeister Center
🇺🇸Columbus, Ohio, United States
Armes Family Cancer Center
🇺🇸Findlay, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
Springfield Regional Cancer Center
🇺🇸Springfield, Ohio, United States
Genesis Healthcare System Cancer Care Center
🇺🇸Zanesville, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
🇺🇸Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
🇺🇸Lewisburg, Pennsylvania, United States
Lewistown Hospital
🇺🇸Lewistown, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Community Medical Center
🇺🇸Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove
🇺🇸Selinsgrove, Pennsylvania, United States
Geisinger Medical Group
🇺🇸State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley
🇺🇸Easley, South Carolina, United States
Gibbs Cancer Center-Gaffney
🇺🇸Gaffney, South Carolina, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
🇺🇸Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
🇺🇸Greenville, South Carolina, United States
Self Regional Healthcare
🇺🇸Greenwood, South Carolina, United States
Prisma Health Cancer Institute - Greer
🇺🇸Greer, South Carolina, United States
Gibbs Cancer Center-Pelham
🇺🇸Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
🇺🇸Seneca, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union
🇺🇸Union, South Carolina, United States
Sanford Cancer Center Oncology Clinic
🇺🇸Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Duluth Clinic Ashland
🇺🇸Ashland, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
🇺🇸Green Bay, Wisconsin, United States
Marshfield Medical Center-Marshfield
🇺🇸Marshfield, Wisconsin, United States
Marshfield Medical Center - Minocqua
🇺🇸Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake
🇺🇸Rice Lake, Wisconsin, United States
Essentia Health-Spooner Clinic
🇺🇸Spooner, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
🇺🇸Stevens Point, Wisconsin, United States
Marshfield Medical Center - Weston
🇺🇸Weston, Wisconsin, United States