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

Inclusion Criteria

• Older adults (age >= 60 years [y]) with either * Newly diagnosed metastatic CRC or * Newly recognized metastatic recurrence of CRC greater than 1 year from completion of treatment for non-metastatic CRC.
• Planning to undergo immunotherapy and/or 5-FU based chemotherapy as 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 body mass index (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 (acceptable if adjuvant chemotherapy completed >= 12 months prior to disease recurrence).
• 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

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 greater than 1 year 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.

OUTLINE:

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.

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

Trial Phase Phase NA

Trial Type Ancillary-correlative

Lead Organization
Wake Forest NCORP Research Base

Principal Investigator
Grant R. Williams

• Primary ID WF-1806
• Secondary IDs NCI-2019-02514
• Clinicaltrials.gov ID NCT03998202