Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
M&M
3 other identifiers
observational
300
1 country
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 8, 2026
January 1, 2026
7.3 years
June 21, 2019
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Up to 6 months (after initiation of chemotherapy)
Secondary Outcomes (1)
Overall Survival
1 year
Study Arms (2)
Adults 60-74 years
Adults >= 75 years
Eligibility Criteria
Diagnosed metastatic CRC or metastatic recurrence of CRC \>= 3 months (12 weeks) from diagnosis at 60 years or older.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (146)
Beebe South Coastal Health Campus
Millville, Delaware, 19967, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Carle Physician Group - Mattoon/Charleston
Mattoon, Illinois, 61938, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Carle BroMenn Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
The University of Iowa - Ankeny
Ankeny, Iowa, 50023, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
The University of Iowa-Des Moines
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
MBP Cancer Center - Baton Rouge General
Baton Rouge, Louisiana, 70809, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology-Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center-Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Hematology Oncology Consultants-Chelsea Hospital
Chelsea, Michigan, 48118, United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Marshfield Medical Center Dickinson
Iron Mountain, Michigan, 49801, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Trinity Health IHA Medical Group Hematology Oncology -Ann Arbor
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210, United States
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211, United States
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262, United States
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025, United States
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054, United States
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina, 28659, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Biospecimen
Whole blood obtained for DNA extraction
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Glenn Lesser, MD
WFUSM
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 26, 2019
Study Start
September 23, 2019
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon to request to NCORP@wakehealth.edu
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.