Colorectal Cancer Clinical Trial
— M&MOfficial title:
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | OSF Saint Anthony's Health Center | Alton | Illinois |
| United States | Trinity Health Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
| United States | Duluth Clinic Ashland | Ashland | Wisconsin |
| 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 | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota |
| United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
| United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
| United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
| United States | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina |
| United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
| United States | Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota |
| United States | Trinity Health IHA Medical Group Hematology Oncology-Brighton | Brighton | Michigan |
| United States | Trinity Health Medical Center-Brighton | Brighton | Michigan |
| United States | Illinois CancerCare-Canton | Canton | Illinois |
| United States | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan |
| United States | Trinity Health Medical Center - Canton | Canton | Michigan |
| United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
| United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
| United States | Saint Anthony Regional Hospital | Carroll | Iowa |
| United States | Illinois CancerCare-Carthage | Carthage | Illinois |
| United States | Mercy Hospital | Cedar Rapids | Iowa |
| United States | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa |
| United States | Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa |
| United States | Chelsea Hospital | Chelsea | Michigan |
| United States | Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital | Chelsea | Michigan |
| United States | John H Stroger Jr Hospital of Cook County | Chicago | Illinois |
| United States | Adena Regional Medical Center | Chillicothe | Ohio |
| United States | Wake Forest University at Clemmons | Clemmons | North Carolina |
| United States | Columbus NCI Community Oncology Research Program | Columbus | Ohio |
| United States | Doctors Hospital | Columbus | Ohio |
| United States | Grant Medical Center | Columbus | Ohio |
| United States | The Mark H Zangmeister Center | Columbus | Ohio |
| United States | Mercy Hospital | Coon Rapids | Minnesota |
| United States | Carle at The Riverfront | Danville | Illinois |
| United States | Carle on Vermilion | Danville | Illinois |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | Dayton NCI Community Oncology Research Program | Dayton | Ohio |
| United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
| United States | Decatur Memorial Hospital | Decatur | Illinois |
| United States | Heartland Cancer Research NCORP | Decatur | Illinois |
| United States | Essentia Health - Deer River Clinic | Deer River | Minnesota |
| United States | Delaware Health Center-Grady Cancer Center | Delaware | Ohio |
| United States | Broadlawns Medical Center | Des Moines | Iowa |
| United States | Iowa Lutheran Hospital | Des Moines | Iowa |
| United States | Iowa Methodist Medical Center | Des Moines | Iowa |
| United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
| United States | Mission Cancer and Blood-Des Moines | Des Moines | Iowa |
| United States | Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota |
| United States | Essentia Health Cancer Center | Duluth | Minnesota |
| United States | Prisma Health Cancer Institute - Easley | Easley | South Carolina |
| United States | HSHS Sacred Heart Hospital | Eau Claire | Wisconsin |
| United States | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin |
| United States | Fairview Southdale Hospital | Edina | Minnesota |
| United States | Crossroads Cancer Center | Effingham | Illinois |
| United States | Illinois CancerCare-Eureka | Eureka | Illinois |
| 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 | Parkland Health Center - Farmington | Farmington | Missouri |
| United States | Armes Family Cancer Center | Findlay | Ohio |
| 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 Regional Medical Center | Fort Dodge | Iowa |
| United States | Holy Cross Hospital | Fort Lauderdale | Florida |
| United States | Mercy Hospital Fort Smith | Fort Smith | Arkansas |
| United States | Beebe South Coastal Health Campus | Frankford | Delaware |
| United States | Unity Hospital | Fridley | Minnesota |
| United States | Gibbs Cancer Center-Gaffney | Gaffney | South Carolina |
| United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
| United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
| United States | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan |
| United States | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin |
| United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
| United States | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina |
| United States | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina |
| United States | Prisma Health Cancer Institute - Faris | Greenville | South Carolina |
| United States | Self Regional Healthcare | Greenwood | South Carolina |
| United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
| United States | Prisma Health Cancer Institute - Greer | Greer | South Carolina |
| United States | HaysMed University of Kansas Health System | Hays | Kansas |
| United States | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania |
| United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
| United States | Essentia Health Hibbing Clinic | Hibbing | Minnesota |
| United States | Terrebonne General Medical Center | Houma | Louisiana |
| United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
| United States | Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania |
| United States | Lewistown Hospital | Lewistown | Pennsylvania |
| United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
| United States | Illinois CancerCare-Macomb | Macomb | Illinois |
| United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
| United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
| United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
| United States | Carle Physician Group - Mattoon/Charleston | Mattoon | Illinois |
| United States | Health Partners Inc | Minneapolis | Minnesota |
| United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
| United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
| United States | New Ulm Medical Center | New Ulm | Minnesota |
| United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
| United States | Delaware Clinical and Laboratory Physicians PA | Newark | Delaware |
| United States | Helen F Graham Cancer Center | Newark | Delaware |
| United States | Licking Memorial Hospital | Newark | Ohio |
| United States | Medical Oncology Hematology Consultants PA | Newark | Delaware |
| United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
| United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
| United States | Essentia Health - Park Rapids | Park Rapids | Minnesota |
| United States | Illinois CancerCare-Pekin | Pekin | Illinois |
| United States | Illinois CancerCare-Peoria | Peoria | Illinois |
| United States | Methodist Medical Center of Illinois | Peoria | Illinois |
| United States | Illinois CancerCare-Peru | Peru | Illinois |
| United States | Valley Radiation Oncology | Peru | Illinois |
| United States | Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan |
| United States | Southern Ohio Medical Center | Portsmouth | Ohio |
| United States | Geisinger Cancer Services-Pottsville | Pottsville | Pennsylvania |
| United States | Illinois CancerCare-Princeton | Princeton | Illinois |
| United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
| United States | Beebe Health Campus | Rehoboth Beach | Delaware |
| United States | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin |
| United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
| United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
| 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 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
| United States | Salina Regional Health Center | Salina | Kansas |
| United States | Essentia Health Sandstone | Sandstone | Minnesota |
| United States | Community Medical Center | Scranton | Pennsylvania |
| United States | Geisinger Medical Oncology-Selinsgrove | Selinsgrove | Pennsylvania |
| United States | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina |
| United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
| United States | LSU Health Sciences Center at Shreveport | Shreveport | Louisiana |
| United States | Ochsner LSU Health Saint Mary's Medical Center | Shreveport | Louisiana |
| 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 | Spartanburg Medical Center | Spartanburg | South Carolina |
| United States | Essentia Health-Spooner Clinic | Spooner | Wisconsin |
| United States | CoxHealth South Hospital | Springfield | Missouri |
| United States | Mercy Hospital Springfield | Springfield | Missouri |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | Springfield Clinic | Springfield | Illinois |
| United States | Springfield Memorial Hospital | Springfield | Illinois |
| United States | Springfield Regional Cancer Center | Springfield | Ohio |
| United States | Geisinger Medical Group | State College | Pennsylvania |
| United States | Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin |
| United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
| United States | BJC Outpatient Center at Sunset Hills | Sunset Hills | Missouri |
| United States | MGC Hematology Oncology-Union | Union | South Carolina |
| United States | Carle Cancer Center | Urbana | Illinois |
| United States | The Carle Foundation Hospital | Urbana | Illinois |
| United States | Essentia Health Virginia Clinic | Virginia | Minnesota |
| United States | Illinois CancerCare - Washington | Washington | Illinois |
| United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
| United States | Methodist West Hospital | West Des Moines | Iowa |
| United States | Marshfield Medical Center - Weston | Weston | Wisconsin |
| United States | University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas |
| United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
| United States | Wake Forest Baptist Health - Wilkes Medical Center | Wilkesboro | North Carolina |
| United States | Rice Memorial Hospital | Willmar | Minnesota |
| United States | Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware |
| United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
| United States | University of Michigan Health - West | Wyoming | Michigan |
| United States | Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor | Ypsilanti | Michigan |
| United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Wake Forest University Health Sciences | University of Alabama at Birmingham |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Chemotherapy Toxicities (Grade 3 - 5) | Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). | Up to 6 months (after initiation of chemotherapy) | |
| Secondary | Overall Survival | 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. | 1 year |
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