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

Recruiting

• Conditions: Colorectal Cancer; Sarcopenia

• Registration Number: NCT03998202
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-26
• Study Start: 2019-09-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Chemotherapy Toxicities (Grade 3 - 5)	Up to 6 months (after initiation of chemotherapy)	Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

Secondary Outcome Measures

Name	Time	Method
Overall Survival	1 year	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.

Trial Locations

Locations (143)

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, 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

John H Stroger Jr Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

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