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Search / Trial NCT03998202

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

Colorectal Cancer Myopenia Sarcopenia Chemotherapy Geriatric Oncology

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.

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

Newark, Delaware, United States

Newark, Delaware, United States

Newark, Delaware, United States

Rehoboth Beach, Delaware, United States

Wilmington, Delaware, United States

Brighton, Michigan, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Canton, Michigan, United States

Chelsea, Michigan, United States

Chelsea, Michigan, United States

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

0 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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