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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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. If unable to engage patient before treatment starts, enrollment is allowed up to four weeks after the start of treatment but must be before Cycle 2 begins.
* 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. (For clarity, participants on the Alliance A021703 trial are also eligible for this study).
* No untreated brain metastases. Patients with treated brain metastases are eligible.
* Patients on or planned to undergo radiation therapy in near future.

Where it's running

• Beebe South Coastal Health Campus
  Millville, Delaware, United States Recruiting
• Helen F Graham Cancer Center
  Newark, Delaware, United States Recruiting
• Medical Oncology Hematology Consultants PA
  Newark, Delaware, United States Recruiting
• Beebe Health Campus
  Rehoboth Beach, Delaware, United States Recruiting
• Christiana Care Health System-Wilmington Hospital
  Wilmington, Delaware, United States Recruiting
• MedStar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting

+97 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Karen Craver
• Email: NCORP@wfusm.edu
• Phone: 336-716-0891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.