LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
Purpose
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.
Conditions
- Advanced Colorectal Carcinoma
- Advanced Lung Non-Small Cell Carcinoma
- Advanced Pancreatic Adenocarcinoma
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Unresectable Colorectal Carcinoma
- Unresectable Lung Non-Small Cell Carcinoma
- Unresectable Pancreatic Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer - Note: Patients do not need to have cachexia to be eligible - Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks. - NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended > 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy [RT]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Be able to understand, speak and read English - Be 18 years of age or older
Exclusion Criteria
- Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee - Have any planned major surgeries within the next 3 months - Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer - Be pregnant
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational (survey, function tests, biospecimen, actigraph) | 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 CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up. |
|
Recruiting Locations
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373
Site Public Contact
800-378-9373
Beebe South Coastal Health Campus
Millville, Delaware 19967
Millville, Delaware 19967
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Newark, Delaware 19718
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
Wilmington, Delaware 19801
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 20007
Contact:
Site Public Contact
202-444-2223
Site Public Contact
202-444-2223
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Northeast Georgia Medical Center Braselton
Braselton, Georgia 30517
Braselton, Georgia 30517
John B Amos Cancer Center
Columbus, Georgia 31904
Columbus, Georgia 31904
Northside Hospital - Duluth
Duluth, Georgia 30096
Duluth, Georgia 30096
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia 30501
Gainesville, Georgia 30501
The Longstreet Clinic - Gainesville
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Contact:
Site Public Contact
770-219-9010
Site Public Contact
770-219-9010
Northside Hospital - Gwinnett
Lawrenceville, Georgia 30046
Lawrenceville, Georgia 30046
Memorial Health University Medical Center
Savannah, Georgia 31404
Savannah, Georgia 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Savannah, Georgia 31405
Tift Regional Medical Center
Tifton, Georgia 31794
Tifton, Georgia 31794
Contact:
Site Public Contact
800-648-1935
Site Public Contact
800-648-1935
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia 31602
Valdosta, Georgia 31602
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-532-0315
Site Public Contact
808-532-0315
Queen's Medical Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548
Site Public Contact
808-545-8548
Straub Clinic and Hospital
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333
Site Public Contact
808-522-4333
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-531-8521
Site Public Contact
808-531-8521
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
Contact:
Site Public Contact
808-983-6090
Site Public Contact
808-983-6090
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
Pali Momi Medical Center
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
Contact:
Site Public Contact
808-486-6000
Site Public Contact
808-486-6000
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
Contact:
Site Public Contact
808-487-7447
Site Public Contact
808-487-7447
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii 96706
‘Ewa Beach, Hawaii 96706
OSF Saint Anthony's Health Center
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623
Site Public Contact
618-463-5623
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847
Site Public Contact
847-842-4847
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360
Site Public Contact
773-296-5360
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Crystal Lake, Illinois 60014
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Advocate Sherman Hospital
Elgin, Illinois 60123
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907
Site Public Contact
847-429-2907
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995
Site Public Contact
708-799-9995
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Condell Memorial Hospital
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Carle BroMenn Medical Center
Normal, Illinois 61761
Normal, Illinois 61761
Carle Cancer Institute Normal
Normal, Illinois 61761
Normal, Illinois 61761
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622
Site Public Contact
800-323-8622
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621
Site Public Contact
847-384-3621
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Springfield Memorial Hospital
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Christiana Care - Union Hospital
Elkton, Maryland 21921
Elkton, Maryland 21921
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Dickinson County Healthcare System
Iron Mountain, Michigan 49801
Iron Mountain, Michigan 49801
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
New Ulm Medical Center
New Ulm, Minnesota 56073
New Ulm, Minnesota 56073
Fairview Northland Medical Center
Princeton, Minnesota 55371
Princeton, Minnesota 55371
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Ridgeview Medical Center
Waconia, Minnesota 55387
Waconia, Minnesota 55387
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
Wyoming, Minnesota 55092
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Lake Regional Hospital
Osage Beach, Missouri 65065
Osage Beach, Missouri 65065
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Mercy Hospital South
St Louis, Missouri 63128
St Louis, Missouri 63128
Missouri Baptist Medical Center
St Louis, Missouri 63131
St Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
Carson City, Nevada 89703
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Henderson, Nevada 89052
OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Henderson, Nevada 89052
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
Henderson, Nevada 89074
Urology Specialists of Nevada - Green Valley
Henderson, Nevada 89074
Henderson, Nevada 89074
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Renown Regional Medical Center
Reno, Nevada 89502
Reno, Nevada 89502
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York 14437
Dansville, New York 14437
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Manhattan Eye Ear and Throat Hospital
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-434-4460
Site Public Contact
212-434-4460
Lenox Hill Hospital
New York, New York 10075
New York, New York 10075
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York 14606
Rochester, New York 14606
Contact:
Site Public Contact
585-758-7877
Site Public Contact
585-758-7877
Highland Hospital
Rochester, New York 14620
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113
Site Public Contact
585-341-8113
Pluta Cancer Center
Rochester, New York 14623
Rochester, New York 14623
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Wilmot Cancer Institute at Webster
Webster, New York 14580
Webster, New York 14580
Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Belpre, Ohio 45714
Marietta Memorial Hospital
Marietta, Ohio 45750
Marietta, Ohio 45750
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Oregon City, Oregon 97045
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
AnMed Health Cancer Center
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina 29910
Bluffton, South Carolina 29910
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
Gaffney, South Carolina 29341
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Greer, South Carolina 29651
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina 29926-3827
Hilton Head Island, South Carolina 29926-3827
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
SMC Center for Hematology Oncology Union
Union, South Carolina 29379
Union, South Carolina 29379
VCU Community Memorial Health Center
South Hill, Virginia 23970
South Hill, Virginia 23970
Shenandoah Oncology PC
Winchester, Virginia 22601
Winchester, Virginia 22601
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Bellingham, Washington 98225
Contact:
Site Public Contact
360-788-8223
Site Public Contact
360-788-8223
PeaceHealth Saint John Medical Center
Longview, Washington 98632
Longview, Washington 98632
Valley Medical Center
Renton, Washington 98055
Renton, Washington 98055
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Vancouver, Washington 98664
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Appleton, Wisconsin 54911
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin 54915
Appleton, Wisconsin 54915
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin 53045
Brookfield, Wisconsin 53045
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Ascension Calumet Hospital
Chilton, Wisconsin 53014
Chilton, Wisconsin 53014
Aurora Saint Luke's South Shore
Cudahy, Wisconsin 53110
Cudahy, Wisconsin 53110
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
Aurora Health Center - Greenfield
Greenfield, Wisconsin 53228
Greenfield, Wisconsin 53228
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin 53097
Mequon, Wisconsin 53097
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53211
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
Ascension Mercy Hospital
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Ascension All Saints Hospital
Racine, Wisconsin 53405
Racine, Wisconsin 53405
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Racine, Wisconsin 53406
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Two Rivers, Wisconsin 54241
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
West Allis, Wisconsin 53227
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT06073431
- Status
- Recruiting
- Sponsor
- University of Rochester
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.