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Examining the effects of low muscle mass on chemotherapy toxicity in older adults with colorectal cancer

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study

Observational Wake Forest University Health Sciences · NCT03998202

This study looks at how having low muscle mass affects the side effects of chemotherapy in older adults with advanced colorectal cancer to see if it impacts their survival.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages60 Years and up
SexAll
SponsorWake Forest University Health Sciences Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations146 sites (Millville, Delaware and 145 other locations)
Trial IDNCT03998202 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between low muscle mass, known as myopenia, and the toxicity of chemotherapy in older adults diagnosed with advanced colorectal cancer. It focuses on patients who are either newly diagnosed with metastatic colorectal cancer or have recently experienced a metastatic recurrence. The study aims to understand how myopenia affects overall survival and whether genetic variations influence this relationship. Participants will be receiving 5-Fluouracil (5FU) chemotherapy as part of their treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are older adults with newly diagnosed metastatic colorectal cancer who are starting or have recently begun chemotherapy.

Not a fit: Patients who are enrolled in hospice care or have previously received systemic chemotherapy for metastatic colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify older patients at risk for chemotherapy toxicity, leading to more personalized treatment plans.

How similar studies have performed: While the specific focus on myopenia and chemotherapy toxicity in older adults is less common, related studies have shown that muscle mass can significantly impact treatment outcomes in cancer patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Millville, Delaware and 145 other locations

+96 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal CancerSarcopeniaMyopeniaChemotherapyGeriatric-Oncology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.