Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 21, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how low muscle mass, also known as myopenia, affects older adults with advanced colorectal cancer when they receive chemotherapy. Researchers want to understand if having less muscle can make chemotherapy more difficult for patients. The study is looking for participants who have recently been diagnosed with metastatic colorectal cancer and are planning to start treatment with specific types of chemotherapy or immunotherapy.
To be eligible for this trial, patients should be at least 21 years old and must have a life expectancy of at least six months. They should also be able to understand English or Spanish to complete questionnaires about their health. It's important to note that patients who are currently in hospice care or have had prior chemotherapy for metastatic colorectal cancer are not eligible. If you join the study, you will help researchers learn more about the effects of muscle mass on treatment outcomes, which could lead to better care for future patients.
Gender
ALL
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.
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Flint, Michigan, United States
Edina, Minnesota, United States
Peoria, Illinois, United States
Baton Rouge, Louisiana, United States
Des Moines, Iowa, United States
Saint Paul, Minnesota, United States
Lewistown, Pennsylvania, United States
Mount Vernon, Illinois, United States
Salina, Kansas, United States
Houma, Louisiana, United States
Chillicothe, Ohio, United States
Coon Rapids, Minnesota, United States
Urbana, Illinois, United States
Carroll, Iowa, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Willmar, Minnesota, United States
State College, Pennsylvania, United States
Effingham, Illinois, United States
Saint Joseph, Missouri, United States
Mount Vernon, Ohio, United States
Springfield, Illinois, United States
Danville, Pennsylvania, United States
Birmingham, Alabama, United States
Washington, District Of Columbia, United States
Decatur, Illinois, United States
Grand Rapids, Michigan, United States
Duluth, Minnesota, United States
Saint Louis, Missouri, United States
Winston Salem, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Newark, Delaware, United States
Charlotte, North Carolina, United States
Wyoming, Michigan, United States
Cape Girardeau, Missouri, United States
Fridley, Minnesota, United States
Saint Louis Park, Minnesota, United States
Fort Lauderdale, Florida, United States
Sioux Falls, South Dakota, United States
Green Bay, Wisconsin, United States
Marshfield, Wisconsin, United States
Decatur, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Galesburg, Illinois, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Brainerd, Minnesota, United States
Reed City, Michigan, United States
Peru, Illinois, United States
Maplewood, Minnesota, United States
Maplewood, Minnesota, United States
Hazleton, Pennsylvania, United States
Wilkes Barre, Pennsylvania, United States
Spartanburg, South Carolina, United States
Scranton, Pennsylvania, United States
Columbus, Georgia, United States
Galesburg, Illinois, United States
Bemidji, Minnesota, United States
Springfield, Missouri, United States
Springfield, Missouri, United States
Dayton, Ohio, United States
Sioux Falls, South Dakota, United States
Eau Claire, Wisconsin, United States
Green Bay, Wisconsin, United States
Minocqua, Wisconsin, United States
Rice Lake, Wisconsin, United States
Weston, Wisconsin, United States
Chicago, Illinois, United States
Cedar Rapids, Iowa, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Newark, Ohio, United States
Zanesville, Ohio, United States
Livonia, Michigan, United States
New Ulm, Minnesota, United States
Hendersonville, North Carolina, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Fargo, North Dakota, United States
Shreveport, Louisiana, United States
Greenville, South Carolina, United States
Fort Smith, Arkansas, United States
Bloomington, Illinois, United States
Pekin, Illinois, United States
Hays, Kansas, United States
Concord, North Carolina, United States
Boiling Springs, South Carolina, United States
Easley, South Carolina, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Greenwood, South Carolina, United States
Greer, South Carolina, United States
Seneca, South Carolina, United States
West Des Moines, Iowa, United States
Rolla, Missouri, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Portsmouth, Ohio, United States
Urbana, Illinois, United States
Springfield, Illinois, United States
Delaware, Ohio, United States
Springfield, Ohio, United States
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Rehoboth Beach, Delaware, United States
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Flint, Michigan, United States
Flint, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Lewisburg, Pennsylvania, United States
Lexington, Kentucky, United States
Carbondale, Illinois, United States
Danville, Illinois, United States
Decatur, Illinois, United States
O'fallon, Illinois, United States
Canton, Michigan, United States
Bonne Terre, Missouri, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Sunset Hills, Missouri, United States
Findlay, Ohio, United States
Sturgeon Bay, Wisconsin, United States
Pottsville, Pennsylvania, United States
Baton Rouge, Louisiana, United States
Gaffney, South Carolina, United States
Greer, South Carolina, United States
Union, South Carolina, United States
Eau Claire, Wisconsin, United States
Stevens Point, Wisconsin, United States
Des Moines, Iowa, United States
Westwood, Kansas, United States
Selinsgrove, Pennsylvania, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Stevens Point, Wisconsin, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Ashland, Wisconsin, United States
Fort Dodge, Iowa, United States
Detroit Lakes, Minnesota, United States
Park Rapids, Minnesota, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Frankford, Delaware, United States
Shreveport, Louisiana, United States
Clemmons, North Carolina, United States
Wilkesboro, North Carolina, United States
Gastonia, North Carolina, United States
Spooner, Wisconsin, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Mattoon, Illinois, United States
Wyoming, Michigan, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Chelsea, Michigan, United States
Danville, Illinois, United States
Canton, Michigan, United States
Minocqua, Wisconsin, United States
Barrington, Illinois, United States
Bloomington, Illinois, United States
Bloomington, Illinois, United States
Centralia, Illinois, United States
Downers Grove, Illinois, United States
Galesburg, Illinois, United States
Normal, Illinois, United States
Oak Lawn, Illinois, United States
Richmond, Illinois, United States
Springfield, Illinois, United States
Springfield, Illinois, United States
Reidsville, North Carolina, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Reed City, Michigan, United States
Baton Rouge, Louisiana, United States
Des Moines, Iowa, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Ypsilanti, Michigan, United States
Millville, Delaware, United States
Flint, Michigan, United States
Mount Vernon, Illinois, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Ankeny, Iowa, United States
Des Moines, Iowa, United States
Iron Mountain, Michigan, United States
Patients applied
Trial Officials
Grant R Williams, MD
Principal Investigator
University of Alabama at Birmingham
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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