Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
Summary
This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
Detailed description
PRIMARY OBJECTIVE: I. To identify multiple distinct diagnostic subtypes within the syndrome of CC as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. SECONDARY OBJECTIVES: I. To determine the association of each CC phenotype with overall survival. II. To validate CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by our collaborators at Kaiser Permanente. III. To collect human samples of blood, tumor tissue, and medical images and build a large, comprehensive CC database clinically annotated with cancer-related outcomes, cachexia symptoms, and physical function data. EXPLORATORY OBJECTIVE: I. To evaluate for tumor-derived factors contributing to CC by determining the association between interleukin-6 (IL-6) expression in tumor and IL-6 and CC chemokine ligand 2 (CCL2) levels in the blood in patients with CC. OUTLINE: This is an observational study. Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care computed tomography (CT) or positron emission tomography (PET)/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood and archived tumor samples
- ProcedureComputed Tomography
Undergo CT or PET/CT scan
- OtherElectronic Health Record Review
Medical records reviewed
- OtherMedical Device Usage and Evaluation
Wear actigraph
- OtherPhysical Performance Testing
Undergo physical function tests
- ProcedurePositron Emission Tomography
Undergo PET/CT scan
- OtherSurvey Administration
Complete surveys
Outcome measures
Primary
Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)
Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding conditions that are too rare (\< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson or Spearman correlation for continuous variables to determine highly correlated variables that may provide redundant information.
Time frame: Baseline through study completion, assessed up to 1 year follow up
Secondary
Association of each CC phenotype (clusters) with overall survival
Time frame: Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente
Time frame: Up to study completion, assessed up to 1 year
Eligibility criteria
Study locations (225)
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
The Women's Imaging Center
Denver, Colorado, 80209
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Northside Hospital
Atlanta, Georgia, 30342
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
John B Amos Cancer Center
Columbus, Georgia, 31904
Northside Hospital - Duluth
Duluth, Georgia, 30096
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
The Longstreet Clinic - Gainesville
Gainesville, Georgia, 30501
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
Memorial Health University Medical Center
Savannah, Georgia, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Tift Regional Medical Center
Tifton, Georgia, 31794
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Illinois CancerCare-Canton
Canton, Illinois, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Centralia Oncology Clinic
Centralia, Illinois, 62801
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Crossroads Cancer Center
Effingham, Illinois, 62401
Advocate Sherman Hospital
Elgin, Illinois, 60123
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Condell Memorial Hospital
Libertyville, Illinois, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Carle BroMenn Medical Center
Normal, Illinois, 61761
Carle Cancer Institute Normal
Normal, Illinois, 61761
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Illinois CancerCare-Peru
Peru, Illinois, 61354
Valley Radiation Oncology
Peru, Illinois, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Carle Cancer Center
Urbana, Illinois, 61801
Illinois CancerCare - Washington
Washington, Illinois, 61571
Reid Health
Richmond, Indiana, 47374
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Mercy Hospital
Coon Rapids, Minnesota, 55433
Fairview Southdale Hospital
Edina, Minnesota, 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Monticello Cancer Center
Monticello, Minnesota, 55362
New Ulm Medical Center
New Ulm, Minnesota, 56073
Fairview Northland Medical Center
Princeton, Minnesota, 55371
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Lakeview Hospital
Stillwater, Minnesota, 55082
Ridgeview Medical Center
Waconia, Minnesota, 55387
Rice Memorial Hospital
Willmar, Minnesota, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Lake Regional Hospital
Osage Beach, Missouri, 65065
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Mercy Hospital Springfield
Springfield, Missouri, 65804
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Renown Regional Medical Center
Reno, Nevada, 89502
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606
Highland Hospital
Rochester, New York, 14620
Pluta Cancer Center
Rochester, New York, 14623
University of Rochester
Rochester, New York, 14642
Wilmot Cancer Institute at Webster
Webster, New York, 14580
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
Armes Family Cancer Center
Findlay, Ohio, 45840
Blanchard Valley Hospital
Findlay, Ohio, 45840
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Wayne Hospital
Greenville, Ohio, 45331
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Kettering Medical Center
Kettering, Ohio, 45429
Marietta Memorial Hospital
Marietta, Ohio, 45750
Dayton Physicians LLC - Troy
Troy, Ohio, 45373
Saint Joseph Warren Hospital
Warren, Ohio, 44484
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
Providence Newberg Medical Center
Newberg, Oregon, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Shenandoah Oncology PC
Winchester, Virginia, 22601
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Valley Medical Center
Renton, Washington, 98055
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Aurora Health Center - Greenfield
Greenfield, Wisconsin, 53228
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Ascension All Saints Hospital
Racine, Wisconsin, 53405
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476