Myopenia for Colorectal Cancer

(M&M Trial)

Recruiting at 211 trial locations

Overseen By Karen Craver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Immunotherapy, 5-FU chemotherapy

Must not be taking: Investigational agents

Disqualifiers: Hospice, Prior chemotherapy, Untreated brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how low muscle mass (myopenia) affects chemotherapy side effects in older adults with advanced colorectal cancer. Researchers seek to determine if less muscle at diagnosis increases the risk of severe chemotherapy side effects. Participants will either begin or have recently begun treatments like immunotherapy or 5-FU-based chemotherapy. Suitable candidates have recently been diagnosed with advanced colorectal cancer and are planning to start or have just started these treatments. Eligibility requires understanding English or Spanish and having a life expectancy of at least six months. As an unphased trial, this study offers a unique opportunity to contribute to understanding how muscle mass impacts chemotherapy side effects, potentially improving future treatment approaches.

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to uncover how myopenia, a condition characterized by muscle wasting, might influence chemotherapy toxicity in older adults with colorectal cancer. Unlike current treatments that focus primarily on targeting cancer cells, this research aims to explore the underlying mechanisms that could improve the tolerability and effectiveness of chemotherapy. By understanding the role of muscle health in chemotherapy outcomes, the findings could lead to more personalized treatment approaches, potentially enhancing the quality of life and treatment success for older cancer patients.

Who Is on the Research Team?

Glenn Lesser, MD

Principal Investigator

WFUSM

Are You a Good Fit for This Trial?

Inclusion Criteria

Newly diagnosed metastatic CRC or metastatic recurrence of CRC >= to 3 months (12 weeks) 1 year from diagnosis at age >= 60y.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive 5-Fluorouracil (5FU) systemic chemotherapy to assess the impact of myopenia on chemotherapy toxicity

Up to 6 months

Follow-up

Participants are monitored for overall survival and chemotherapy toxicity

1 year

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+