Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer (M&M)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Sarcopenia; Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03998202

NCI-2019-02514 (Registry Identifier)

IRB00058811 (Other Identifier)

WF-1806 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Adults 60-74 years

Adults >= 75 years