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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer, Sarcopenia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults 60-74 years<br> | |
| Adults >= 75 years<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Myopenia, Sarcopenia, Chemotherapy, Geriatric-Oncology