Low Muscle Mass and its Role in Side Effects from Chemotherapy and/or Immunotherapy in Older Adults with Colorectal Cancer

PRIMARY OBJECTIVE:

I. To examine the association between low muscle mass (myopenia) at diagnosis with cumulative grades 3-5 toxicity in older adults (>= 60 years) with newly diagnosed metastatic colorectal carcinoma (CRC) or newly recognized metastatic recurrence of CRC >= 3 months (12 weeks) from completion of treatment for non-metastatic CRC undergoing 5-fluorouracil (5-FU) based systemic chemotherapy and/or immunotherapy.

SECONDARY OBJECTIVES:

I. To examine the association between low muscle mass (myopenia) at diagnosis with 1-year overall survival in older adults (>= 60 years) with metastatic CRC.

II. To characterize muscle mass at baseline, and 3 and 6 months after initiation of systemic chemotherapy and/or immunotherapy in older adults with metastatic CRC.

III. Identify distinct trajectories of muscle mass over time in older adults with metastatic CRC and examine the association of trajectories with toxicity and 1 year overall survival.

IV. To examine factors associated with myopenia at baseline and trajectories of muscle loss, including comorbidities, concomitant medications, nutrition, inflammation, physical activity, and age.

V. Examine the role of germline genetic variants in moderating the association between muscle loss and cumulative grades 3-5 toxicity.

VI. To examine factors other than chronologic age that can affect toxicity rates and adverse events as identified using a cancer-specific geriatric assessment.

EXPLORATORY OBJECTIVES:

I. To describe the results of the Was It Worth It (WIWI) questionnaire and Overall Treatment Utility (OTU).

II. To examine the association between low muscle mass at diagnosis and trajectories of muscle loss with functional decline and OTU.

III. To describe the results of the Life-Space Assessment (LSA), and its association with self-reported performance status and muscle measures.

IV. To explore the baseline symptom status of patients on the study and compare symptomatic adverse events reported per the Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) between patients with and without myopenia, and between trajectories of myopenia.

V. To explore the patient’s perception of their quality of life as it relates to the toxicities experienced during treatment using the Functional Assessment of Cancer Therapy General (FACT-G) GP5 assessment tool.

OUTLINE: This is an observational study.

Patients perform physical performance (leg strength, walking, and balance) and hand grip tests over 10 minutes, and respond to questionnaires at baseline, 3 months and at 6 months over 29-31 minutes. Patients undergo blood sample collection and undergo computed tomography (CT) as standard of care on study.

After completion of study, patients are followed up for up to 1 year.