Colorectal CancerM&MNCT03998202
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
An observational study of Colorectal Cancer and Sarcopenia, run by Wake Forest University Health Sciences at 147 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer, Sarcopenia
- How many people
- 300 participants
- Where
- 147 sitesUnited States
- Study dates
- 23 Sep 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older adults (age ≥60y) with either newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC ≥3 months (12 weeks) from completion of treatment of non-metastatic CRC.
Who may be able to join
- 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. If unable to engage patient before treatment starts, enrollment is allowed up to four weeks after the start of treatment but must be before Cycle 2 begins.
- 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.
Who cannot join
- 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. (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.
Trial locations and contacts
147 sites in 1 country. Contact the study team or a site near you to ask about taking part.
147 sites in 1 country
United States147 sites, 134 recruiting
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
225-215-1353, clinicalresearch@marybird.com
Victor Lin
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
225-215-1353, clinicalresearch@marybird.com
Victor Lin
- Recruiting
MBP Cancer Center - Baton Rouge General
Baton Rouge, Louisiana, 70809
DG-ClinicalResearch@marybird.com
Victor Lin
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-241-6251
Ki Young Chung
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
618-985-3333, clinical.research@sih.net
Brian Faller
- Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
319-297-2900
Bhaarat Jenigiri
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
800-804-9376
Kunal Kadakia
- Recruiting
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
980-442-2000
Kunal Kadakia
- Recruiting
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211
980-442-2000
Kunal Kadakia
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
800-804-9376
Kunal Kadakia
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M Tamkus
- Active, not recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
- Recruiting
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Site Public Contact, 888-716-9259
Glenn J. Lesser
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
515-241-3305
Seema Harichand-Herdt
- Recruiting
John B Amos Cancer Center
Columbus, Georgia, 31904
706-478-7968, cdean@iacthealth.com
Andrew Pippas
- Active, not recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
800-804-9376
Kunal Kadakia
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Active, not recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler@dmhhs.org
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
515-358-6613, cancerresearch@mercydesmoines.org
Richard L Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
515-241-3305
Seema Harichand-Herdt
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
218-786-3308 ext. 24308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-2066, kim.williams3@prismahealth.org
Ki Young Chung
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghadadi
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghadadi
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghadadi
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Amarinthia (Amy) Curtis
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054
800-804-9376
Kunal Kadakia
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, ewd_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, ewd_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Ki Young Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Ki Young Chung
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-241-6251
Ki Young Chung
- Withdrawn
Self Regional Healthcare
Greenwood, South Carolina, 29646
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-241-6251
Ki Young Chung
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Amarinthia (Amy) Curtis
- Recruiting
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 570-459-2901, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
218-786-3308
Bret Friday
- Recruiting
Terrebonne General Medical Center
Houma, Louisiana, 70360
985-850-6300, ann.hooks@tgmc.com
Victor Lin
- Recruiting
Marshfield Medical Center Dickinson
Iron Mountain, Michigan, 49801
906-774-1313, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Site Public Contact, 717-242-7703, HemonCCTrials@geisinger.edu
Sorab Gupta
- Withdrawn
Saint Joseph Hospital East
Lexington, Kentucky, 40509
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Recruiting
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Recruiting
Carle Physician Group - Mattoon/Charleston
Mattoon, Illinois, 61938
800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@Beebehealthcare.org
Gregory A. Masters
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Withdrawn
Health Partners Inc
Minneapolis, Minnesota, 55454
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-242-4600
Jay W. Carlson
- Active, not recruiting
Knox Community Hospital
Mount Vernon, Ohio, 43050
- Recruiting
New Ulm Medical Center
New Ulm, Minnesota, 56073
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Active, not recruiting
Licking Memorial Hospital
Newark, Ohio, 43055
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Active, not recruiting
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
- Recruiting
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Site Public Contact, 800-275-6401, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Site Public Contact, 302-291-6730, research@Beebehealthcare.org
Gregory A. Masters
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Withdrawn
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
- Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
816-271-7937, Trisha.England2@mymlc.com
Jay Carlson
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Community Medical Center
Scranton, Pennsylvania, 18510
Site Public Contact, 570-703-4768, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870
Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Site Public Contact, 864-241-6251
Ki Young Chung
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
- Recruiting
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Amarinthia (Amy) Curtis
- Recruiting
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
218-786-3308, CancerTrials@EssentiaHealth.org
Bret EB Friday
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
417-269-4520
Jay Carlson
- Active, not recruiting
Springfield Regional Cancer Center
Springfield, Ohio, 45504
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Geisinger Medical Group
State College, Pennsylvania, 16801
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
920-433-8889, ewd_research_admin@hshs.org
Anthony Jaslowski
- Recruiting
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
SMC Hematology Oncology-Union
Union, South Carolina, 29379
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Amarinthia (Amy) Curtis
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
218-786-3308, CancerTrials@EssentiaHealth.org
Bret Friday
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
309-243-3605, andersonj@illinoiscancercare.com
Bryan Faller
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Site Public Contact, 202-444-2223
Marcus S. Noel
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Emily Schillinger
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Sorab Gupta
- Recruiting
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina, 28659
888-716-9253
Glenn J Lesser
- Recruiting
Rice Memorial Hospital
Willmar, Minnesota, 56201
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Lisa Lafranchi
- Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
302-623-4450, lbarone@christianacare.org
Gregory Masters
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Glenn J. Lesser
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghadadi
- Active, not recruiting
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701
About this study
Official title: Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
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.
Read the detailed 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.
- Conditions
- Colorectal Cancer, Sarcopenia
- Keywords
- Colorectal Cancer, Myopenia, Sarcopenia, Chemotherapy, Geriatric-Oncology
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults 60-74 years | Not described | |
| Adults >= 75 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Chemotherapy Toxicities (Grade 3 - 5)
Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Measured: Up to 6 months (after initiation of chemotherapy)
Secondary outcomes (1)
Overall Survival
Participants will be followed for the duration of the study with each participant followed for at least one year after diagnosis, to determine vital status. Loss-to-follow-up will be minimized by asking participating sites to provide date of last contact every 3 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start23 Sep 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, MD, Study chair, WFUSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998202
- Sponsor's protocol ID
- IRB00058811
- Other IDs
- NCI-2019-02514, WF-1806, IRB00058811
- Acronym
- M&M
- Status last verified
- Nov 2026
- First submitted
- 21 Jun 2019
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
- ClinicalTrials.gov ID
- NCT03998202
- Acronym / sponsor ID
- M&M / IRB00058811
- Conditions
- Colorectal Cancer, Sarcopenia
- Keywords
- Colorectal Cancer, Myopenia, Sarcopenia, Chemotherapy, Geriatric-Oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults 60-74 years | – | – |
| Adults >= 75 years | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults (age ≥60y) with either newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC ≥3 months (12 weeks) from completion of treatment of non-metastatic CRC.
Key inclusion criteria (6 listed)
- 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. If unable to engage patient before treatment starts, enrollment is allowed up to four weeks after the start of treatment but must be before Cycle 2 begins.
- 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.
Key exclusion criteria (5 listed)
- 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. (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Chemotherapy Toxicities (Grade 3 - 5)
Time frame: Up to 6 months (after initiation of chemotherapy)
Chemotoxicity will be measured after initiation of chemotherapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
1 secondary outcome
Overall Survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Lesser, MD study chair
WFUSM
147 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Sarcopenia, run by Wake Forest University Health Sciences at 147 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 147 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Craver (336-716-0891, NCORP@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Chemotherapy Toxicities (Grade 3 - 5) (time frame: Up to 6 months (after initiation of chemotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.