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Could low muscle mass predict chemo toxicity in older cancer patients?

NCT ID NCT03998202

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether low muscle mass (myopenia) is linked to severe side effects from chemotherapy in older adults with advanced colorectal cancer. Researchers will follow 300 newly diagnosed patients to track toxicities and survival. The goal is to better understand who might struggle with treatment, not to test a new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict which older patients are at higher risk for severe chemotherapy side effects, leading to more personalized treatment plans.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve outcomes, and results may not apply to all patients or cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Diagnosed metastatic CRC or metastatic recurrence of CRC \>= 3 months (12 weeks) from diagnosis at 60 years or older.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Sarcopenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    142 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Adena Regional Medical Center

    RECRUITING

    Chillicothe, Ohio, 45601, United States

  • Armes Family Cancer Center

    RECRUITING

    Findlay, Ohio, 45840, United States

    Contact Email: •••••@•••••

  • Atrium Health Cabarrus/LCI-Concord

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Atrium Health Pineville/LCI-Pineville

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Atrium Health University City/LCI-University

    RECRUITING

    Charlotte, North Carolina, 28262, United States

  • BJC Outpatient Center at Sunset Hills

    RECRUITING

    Sunset Hills, Missouri, 63127, United States

  • Beebe Health Campus

    RECRUITING

    Rehoboth Beach, Delaware, 19971, United States

    Contact Email: •••••@•••••

  • Beebe South Coastal Health Campus

    RECRUITING

    Millville, Delaware, 19967, United States

    Contact Email: •••••@•••••

  • Broadlawns Medical Center

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Cancer Care Center of O'Fallon

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Cancer Hematology Centers - Flint

    RECRUITING

    Flint, Michigan, 48503, United States

  • Carle BroMenn Medical Center

    RECRUITING

    Normal, Illinois, 61761, United States

    Contact Email: •••••@•••••

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Cancer Institute Normal

    RECRUITING

    Normal, Illinois, 61761, United States

    Contact Email: •••••@•••••

  • Carle Physician Group - Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • Christiana Care Health System-Wilmington Hospital

    RECRUITING

    Wilmington, Delaware, 19801, United States

  • Community Medical Center

    RECRUITING

    Scranton, Pennsylvania, 18510, United States

    Contact Email: •••••@•••••

  • Corewell Health Reed City Hospital

    RECRUITING

    Reed City, Michigan, 49677, United States

  • CoxHealth South Hospital

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Crossroads Cancer Center

    RECRUITING

    Effingham, Illinois, 62401, United States

  • Duluth Clinic Ashland

    RECRUITING

    Ashland, Wisconsin, 54806, United States

    Contact Email: •••••@•••••

  • Essentia Health - Deer River Clinic

    RECRUITING

    Deer River, Minnesota, 56636, United States

    Contact Email: •••••@•••••

  • Essentia Health - Park Rapids

    RECRUITING

    Park Rapids, Minnesota, 56470, United States

    Contact Email: •••••@•••••

  • Essentia Health Cancer Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Essentia Health Cancer Center-South University Clinic

    RECRUITING

    Fargo, North Dakota, 58103, United States

    Contact Email: •••••@•••••

  • Essentia Health Hibbing Clinic

    RECRUITING

    Hibbing, Minnesota, 55746, United States

  • Essentia Health Saint Joseph's Medical Center

    RECRUITING

    Brainerd, Minnesota, 56401, United States

    Contact Email: •••••@•••••

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    RECRUITING

    Detroit Lakes, Minnesota, 56501, United States

    Contact Email: •••••@•••••

  • Essentia Health Sandstone

    RECRUITING

    Sandstone, Minnesota, 55072, United States

    Contact Email: •••••@•••••

  • Essentia Health Virginia Clinic

    RECRUITING

    Virginia, Minnesota, 55792, United States

    Contact Email: •••••@•••••

  • Essentia Health-Spooner Clinic

    RECRUITING

    Spooner, Wisconsin, 54801, United States

    Contact Email: •••••@•••••

  • Fairview Southdale Hospital

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Geisinger Cancer Services-Pottsville

    RECRUITING

    Pottsville, Pennsylvania, 17901, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Center-Cancer Center Hazleton

    RECRUITING

    Hazleton, Pennsylvania, 18201, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Group

    RECRUITING

    State College, Pennsylvania, 16801, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Oncology-Lewisburg

    RECRUITING

    Lewisburg, Pennsylvania, 17837, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Oncology-Selinsgrove

    RECRUITING

    Selinsgrove, Pennsylvania, 17870, United States

    Contact Email: •••••@•••••

  • Geisinger Wyoming Valley/Henry Cancer Center

    RECRUITING

    Wilkes-Barre, Pennsylvania, 18711, United States

    Contact Email: •••••@•••••

  • Genesee Hematology Oncology PC

    RECRUITING

    Flint, Michigan, 48503, United States

  • Genesis Healthcare System Cancer Care Center

    RECRUITING

    Zanesville, Ohio, 43701, United States

  • Genesys Hurley Cancer Institute

    RECRUITING

    Flint, Michigan, 48503, United States

  • Gibbs Cancer Center-Gaffney

    RECRUITING

    Gaffney, South Carolina, 29341, United States

  • Gibbs Cancer Center-Pelham

    RECRUITING

    Greer, South Carolina, 29651, United States

  • Health Partners Inc

    WITHDRAWN

    Minneapolis, Minnesota, 55454, United States

  • Heartland Regional Medical Center

    RECRUITING

    Saint Joseph, Missouri, 64506, United States

  • Helen F Graham Cancer Center

    RECRUITING

    Newark, Delaware, 19713, United States

  • Illinois CancerCare - Washington

    RECRUITING

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    RECRUITING

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    RECRUITING

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Galesburg

    RECRUITING

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Ottawa Clinic

    RECRUITING

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    RECRUITING

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    RECRUITING

    Peru, Illinois, 61354, United States

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • John B Amos Cancer Center

    RECRUITING

    Columbus, Georgia, 31904, United States

  • John H Stroger Jr Hospital of Cook County

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Knox Community Hospital

    RECRUITING

    Mount Vernon, Ohio, 43050, United States

  • Levine Cancer Institute-Gaston

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Levine Cancer Institute-SouthPark

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Lewistown Hospital

    RECRUITING

    Lewistown, Pennsylvania, 17044, United States

    Contact Email: •••••@•••••

  • Licking Memorial Hospital

    RECRUITING

    Newark, Ohio, 43055, United States

  • Louisiana Hematology Oncology Associates LLC

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

    Contact Email: •••••@•••••

  • MBP Cancer Center - Baton Rouge General

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • MGC Hematology Oncology-Union

    RECRUITING

    Union, South Carolina, 29379, United States

  • Marshfield Medical Center - Minocqua

    RECRUITING

    Minocqua, Wisconsin, 54548, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Weston

    RECRUITING

    Weston, Wisconsin, 54476, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center Dickinson

    RECRUITING

    Iron Mountain, Michigan, 49801, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-EC Cancer Center

    RECRUITING

    Eau Claire, Wisconsin, 54701, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Rice Lake

    RECRUITING

    Rice Lake, Wisconsin, 54868, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-River Region at Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54482, United States

    Contact Email: •••••@•••••

  • Mary Bird Perkins Cancer Center

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

    Contact Email: •••••@•••••

  • MedStar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Medical Oncology Hematology Consultants PA

    RECRUITING

    Newark, Delaware, 19713, United States

  • Mercy Clinic-Rolla-Cancer and Hematology

    WITHDRAWN

    Rolla, Missouri, 65401, United States

  • Mercy Hospital

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • Mercy Hospital Springfield

    RECRUITING

    Springfield, Missouri, 65804, United States

  • Mercy Medical Center - Des Moines

    RECRUITING

    Des Moines, Iowa, 50314, United States

    Contact Email: •••••@•••••

  • Minnesota Oncology Hematology PA-Maplewood

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Missouri Baptist Medical Center

    RECRUITING

    St Louis, Missouri, 63131, United States

  • Missouri Baptist Sullivan Hospital

    RECRUITING

    Sullivan, Missouri, 63080, United States

  • New Ulm Medical Center

    RECRUITING

    New Ulm, Minnesota, 56073, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Park Nicollet Clinic - Saint Louis Park

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Parkland Health Center - Farmington

    RECRUITING

    Farmington, Missouri, 63640, United States

  • Physicians' Clinic of Iowa PC

    RECRUITING

    Cedar Rapids, Iowa, 52402, United States

  • Prisma Health Cancer Institute - Butternut

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Easley

    RECRUITING

    Easley, South Carolina, 29640, United States

  • Prisma Health Cancer Institute - Eastside

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute - Faris

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Greer

    RECRUITING

    Greer, South Carolina, 29650, United States

  • Prisma Health Cancer Institute - Seneca

    RECRUITING

    Seneca, South Carolina, 29672, United States

  • Prisma Health Cancer Institute - Spartanburg

    RECRUITING

    Boiling Springs, South Carolina, 29316, United States

  • Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Rice Memorial Hospital

    RECRUITING

    Willmar, Minnesota, 56201, United States

  • SIH Cancer Institute

    RECRUITING

    Carterville, Illinois, 62918, United States

    Contact Email: •••••@•••••

  • SSM Health Good Samaritan

    RECRUITING

    Mount Vernon, Illinois, 62864, United States

  • Saint Anthony Regional Hospital

    RECRUITING

    Carroll, Iowa, 51401, United States

  • Saint Francis Medical Center

    RECRUITING

    Cape Girardeau, Missouri, 63703, United States

  • Saint Francis Regional Medical Center

    RECRUITING

    Shakopee, Minnesota, 55379, United States

  • Saint John's Hospital - Healtheast

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Saint Joseph Hospital East

    WITHDRAWN

    Lexington, Kentucky, 40509, United States

  • Saint Vincent Hospital Cancer Center Green Bay

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    RECRUITING

    Green Bay, Wisconsin, 54303, United States

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    RECRUITING

    Sturgeon Bay, Wisconsin, 54235-1495, United States

  • Sainte Genevieve County Memorial Hospital

    RECRUITING

    Sainte Genevieve, Missouri, 63670, United States

  • Sanford Bismarck Medical Center

    RECRUITING

    Bismarck, North Dakota, 58501, United States

    Contact Email: •••••@•••••

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford Cancer Center Oncology Clinic

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

    Contact Email: •••••@•••••

  • Sanford Joe Lueken Cancer Center

    RECRUITING

    Bemidji, Minnesota, 56601, United States

    Contact Email: •••••@•••••

  • Sanford Roger Maris Cancer Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57117-5134, United States

    Contact Email: •••••@•••••

  • Self Regional Healthcare

    WITHDRAWN

    Greenwood, South Carolina, 29646, United States

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Southern Ohio Medical Center

    RECRUITING

    Portsmouth, Ohio, 45662, United States

  • Spartanburg Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Springfield Clinic

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Springfield Regional Cancer Center

    RECRUITING

    Springfield, Ohio, 45504, United States

  • Terrebonne General Medical Center

    RECRUITING

    Houma, Louisiana, 70360, United States

  • The Mark H Zangmeister Center

    RECRUITING

    Columbus, Ohio, 43219, United States

  • The University of Iowa - Ankeny

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • The University of Iowa-Des Moines

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Trinity Health IHA Medical Group Hematology Oncology-Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health Medical Center - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health Medical Center-Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    RECRUITING

    Ann Arbor, Michigan, 48106, United States

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    RECRUITING

    Pontiac, Michigan, 48341, United States

    Contact Email: •••••@•••••

  • Trinity Health Saint Mary Mercy Livonia Hospital

    RECRUITING

    Livonia, Michigan, 48154, United States

    Contact Email: •••••@•••••

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    RECRUITING

    Clive, Iowa, 50325, United States

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    RECRUITING

    Fort Dodge, Iowa, 50501, United States

    Contact Email: •••••@•••••

  • United Hospital

    RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • University of Michigan Health - West

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • Wake Forest Baptist Health - Wilkes Medical Center

    RECRUITING

    Wilkesboro, North Carolina, 28659, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Wake Forest University at Clemmons

    RECRUITING

    Clemmons, North Carolina, 27012, United States

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