Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer

Recruiting now

Conditions studied: Colorectal Cancer, Sarcopenia

In brief

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.

Key facts

Study ID

NCT03998202

Run by

Wake Forest University Health Sciences

People needed

300

Starts

2019-09-23

Expected to finish

2026-12-31

Last updated by the study team

2026-01-08

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• Beebe Health Campus — Rehoboth Beach, Delaware, United States (enrolling)
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• John B Amos Cancer Center — Columbus, Georgia, United States (enrolling)
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States (enrolling)
• Illinois CancerCare-Canton — Canton, Illinois, United States (enrolling)
• SIH Cancer Institute — Carterville, Illinois, United States (enrolling)
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States (enrolling)
• Carle at The Riverfront — Danville, Illinois, United States (enrolling)
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States (enrolling)
• Crossroads Cancer Center — Effingham, Illinois, United States (enrolling)
• Illinois CancerCare-Galesburg — Galesburg, Illinois, United States (enrolling)
• Carle Physician Group - Mattoon/Charleston — Mattoon, Illinois, United States (enrolling)
• SSM Health Good Samaritan — Mount Vernon, Illinois, United States (enrolling)
• Carle BroMenn Medical Center — Normal, Illinois, United States (enrolling)
• Carle Cancer Institute Normal — Normal, Illinois, United States (enrolling)
• Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States (enrolling)
• Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States (enrolling)
• Illinois CancerCare-Pekin — Pekin, Illinois, United States (enrolling)
• Illinois CancerCare-Peoria — Peoria, Illinois, United States (enrolling)
• Illinois CancerCare-Peru — Peru, Illinois, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• Beebe South Coastal Health Campus — Millville, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

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