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Myopenia and Mechanisms of Ch...

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

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-23

Study Completion Date

2026-12-31

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.

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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.

Conditions

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Colorectal Cancer Sarcopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults 60-74 years

No interventions assigned to this group

Adults >= 75 years

No interventions assigned to this group

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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Lesser, MD

Role: STUDY_CHAIR

WFUSM

Locations

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Beebe South Coastal Health Campus

Millville, Delaware, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

John B Amos Cancer Center

Columbus, Georgia, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

SIH Cancer Institute

Carterville, Illinois, United States

Site Status RECRUITING

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Carle Physician Group - Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Site Status RECRUITING

Carle BroMenn Medical Center

Normal, Illinois, United States

Site Status RECRUITING

Carle Cancer Institute Normal

Normal, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

The University of Iowa - Ankeny

Ankeny, Iowa, United States

Site Status RECRUITING

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status RECRUITING

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status RECRUITING