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Myopenia and Chemotherapy Toxicity in Older Adults with Colorectal Cancer

This observational study is looking at how low muscle mass (myopenia) at the time of diagnosis might affect side effects from chemotherapy in older adults with advanced colorectal cancer. Researchers are studying people aged 60 and older who have newly diagnosed metastatic colorectal cancer or a recurrence, and who are starting or have recently started immunotherapy and/or 5-FU based chemotherapy. The main goal is to see how many severe chemotherapy side effects (Grade 3-5 toxicities) occur within six months of starting chemotherapy. This study is currently unclear on its recruitment status and aims to enroll 300 participants.

Study design
This is an observational study that plans to enroll 300 participants. It is a prospective cohort study, meaning researchers will follow participants over time.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures chemotherapy toxicities up to 6 months after starting chemotherapy.

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NCT03998202

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

Recruiting
Not specifiedAges 60+Observational
Wake Forest University Health Sciences
~300 participants
Updated 2026-01-08 on ClinicalTrials.gov

At a glance

Recruiting sites
142 of 146 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Chemotherapy Toxicities (Grade 3 - 5)
Measured over Up to 6 months (after initiation of chemotherapy)

Conditions

Colorectal Cancer
Sarcopenia

Explore related trials

Colorectal Carcinoma

Where it's being run

146 sites across 17 states
Illinois21
Minnesota21
Michigan16
South Carolina12
Iowa11
Wisconsin11
Missouri10
North Carolina9

Study leadership

  • Glenn Lesser, MD · STUDY_CHAIR · WFUSM

Who to contact

Karen Craver
[email protected]
336-716-0891
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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).