Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting · NCT03998202 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
60 locations listed across 17 US states.
- Beebe South Coastal Health Campus - Millville, 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
- Christiana Care Health System-Wilmington Hospital - Wilmington, Delaware, United States
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- John B Amos Cancer Center - Columbus, Georgia, United States
- Illinois CancerCare-Bloomington - Bloomington, Illinois, United States
- Illinois CancerCare-Canton - Canton, Illinois, United States
- SIH Cancer Institute - Carterville, 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
- SSM Health Good Samaritan - Mount Vernon, Illinois, United States
- Carle BroMenn Medical Center - Normal, Illinois, United States
- Carle Cancer Institute Normal - Normal, 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
- The University of Iowa - 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
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic - Clive, Iowa, United States
- Iowa Methodist Medical Center - Des Moines, Iowa, United States
- The University of Iowa-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
- UI Health Care Mission Cancer and Blood - Laurel Clinic - Des Moines, Iowa, United States
- UI Healthcare Mission Cancer and Blood - Fort Dodge - 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
- Cancer Hematology Centers - Flint - Flint, Michigan, United States
- Genesee Hematology Oncology PC - Flint, Michigan, United States
- Genesys Hurley Cancer Institute - Flint, Michigan, United States
- Marshfield Medical Center Dickinson - Iron Mountain, 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
Showing 60 of 146 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →