RecruitingNCT03998202
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
Sponsor
Wake Forest University Health Sciences
Enrollment
300 participants
Start Date
Sep 23, 2019
Study Type
OBSERVATIONAL
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.
Eligibility
Min Age: 60 Years
Inclusion Criteria6
- 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 Criteria5
- 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.
Locations(146)
View Full Details on ClinicalTrials.gov
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NCT03998202