An Observational Research Study to Uncover Subtypes of Cancer Cachexia
- Conditions
- Advanced Colorectal CarcinomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Pancreatic AdenocarcinomaStage IV Colorectal Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Unresectable Colorectal CarcinomaUnresectable Lung Non-Small Cell CarcinomaUnresectable Pancreatic Adenocarcinoma
- Registration Number
- NCT06073431
- Lead Sponsor
- University of Rochester NCORP Research Base
- Brief 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). 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 positron emission tomography (PET)/computed tomography (CT) scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
-
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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC) Baseline through study completion, assessed up to 1 year follow up 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 g 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 correlation for continuous variables to determine highly correlated variables that may provide redundant information.
- Secondary Outcome Measures
Name Time Method Association of each CC phenotype (clusters) with overall survival Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up Will be assessed in the Cox regression model. Will estimate the bivariate association where the only independent variables will be the indicators for the cluster membership. Will report the hazard ratio for the association of each CC phenotype, specifying the lowest-risk cluster as the reference. Will assess the influence of selected factors (e.g., age, performance status, and other known prognostic factors) on the association of the cluster with survival by adding the factor to the model as a covariate and keeping those that resulted in 10% or more change in any regression coefficients for cluster membership. Will assess if the association of clusters with survival varies by specific subgroups (e.g., older versus younger age, gender, and cancer type). Will assess the statistical significance interaction of the subgroup with the cluster membership by maximum likelihood test and evaluate the regression coefficients for clusters in each subgroup comparing the direction and magnitude.
Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente Up to study completion, assessed up to 1 year Study participants will be categorized into the Kaiser Permanente Medical Care (KPMC)-derived CC phenotype groups. Will use the final latent class analysis model fit in the KPMC data to compute the posterior probabilities of membership in each latent class for each individual National Cancer Institute Community Oncology Research Program (NCORP) participant based on his/her individual data. Will compare cluster prevalence in each cohort as well as the distributions of the variables used to determine each cluster to investigate patterns of commonality and dissimilarity across the contributing variables. Validation will be determined by fitting University of Rochester Cancer Center (URCC) NCORP participants in KPMC-derived clusters and evaluating each cluster's association with survival. If the ranking of survival (best to worst) among each cluster in the URCC NCORP dataset mirrors the prognostic ranking of clusters in the KPMC dataset, the clusters will be deemed validated.
Trial Locations
- Locations (195)
Mercy Hospital Fort Smith
🇺🇸Ft. Smith, Arkansas, United States
Rocky Mountain Cancer Centers-Aurora
🇺🇸Aurora, Colorado, United States
Boulder Community Foothills Hospital
🇺🇸Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
🇺🇸Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
🇺🇸Centennial, Colorado, United States
The Women's Imaging Center
🇺🇸Denver, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
🇺🇸Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
🇺🇸Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
🇺🇸Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
🇺🇸Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
🇺🇸Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
🇺🇸Thornton, Colorado, United States
Beebe South Coastal Health Campus
🇺🇸Millville, Delaware, United States
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
🇺🇸Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Beebe Health Campus
🇺🇸Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington Hospital
🇺🇸Wilmington, Delaware, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Northeast Georgia Medical Center Braselton
🇺🇸Braselton, Georgia, United States
John B Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Northside Hospital - Duluth
🇺🇸Duluth, Georgia, United States
Northeast Georgia Medical Center-Gainesville
🇺🇸Gainesville, Georgia, United States
The Longstreet Clinic - Gainesville
🇺🇸Gainesville, Georgia, United States
Northside Hospital - Gwinnett
🇺🇸Lawrenceville, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
🇺🇸Savannah, Georgia, United States
Tift Regional Medical Center
🇺🇸Tifton, Georgia, United States
South Georgia Medical Center/Pearlman Cancer Center
🇺🇸Valdosta, Georgia, United States
Hawaii Cancer Care - Westridge
🇺🇸Aiea, Hawaii, United States
Pali Momi Medical Center
🇺🇸Aiea, Hawaii, United States
Queen's Cancer Center - Pearlridge
🇺🇸Aiea, Hawaii, United States
The Queen's Medical Center - West Oahu
🇺🇸Ewa Beach, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
🇺🇸Honolulu, Hawaii, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Advocate Good Shepherd Hospital
🇺🇸Barrington, Illinois, United States
Illinois CancerCare-Bloomington
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Canton
🇺🇸Canton, Illinois, United States
Memorial Hospital of Carbondale
🇺🇸Carbondale, Illinois, United States
SIH Cancer Institute
🇺🇸Carterville, Illinois, United States
Illinois CancerCare-Carthage
🇺🇸Carthage, Illinois, United States
Centralia Oncology Clinic
🇺🇸Centralia, Illinois, United States
Advocate Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
AMG Crystal Lake - Oncology
🇺🇸Crystal Lake, Illinois, United States
Carle at The Riverfront
🇺🇸Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
🇺🇸Decatur, Illinois, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Illinois CancerCare-Dixon
🇺🇸Dixon, Illinois, United States
Advocate Good Samaritan Hospital
🇺🇸Downers Grove, Illinois, United States
Crossroads Cancer Center
🇺🇸Effingham, Illinois, United States
Advocate Sherman Hospital
🇺🇸Elgin, Illinois, United States
Illinois CancerCare-Eureka
🇺🇸Eureka, Illinois, United States
Illinois CancerCare-Galesburg
🇺🇸Galesburg, Illinois, United States
Advocate South Suburban Hospital
🇺🇸Hazel Crest, Illinois, United States
Illinois CancerCare-Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
AMG Libertyville - Oncology
🇺🇸Libertyville, Illinois, United States
Condell Memorial Hospital
🇺🇸Libertyville, Illinois, United States
Illinois CancerCare-Macomb
🇺🇸Macomb, Illinois, United States
Carle BroMenn Medical Center
🇺🇸Normal, Illinois, United States
Cancer Care Center of O'Fallon
🇺🇸O'Fallon, Illinois, United States
HSHS Saint Elizabeth's Hospital
🇺🇸O'Fallon, Illinois, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Advocate Outpatient Center - Oak Lawn
🇺🇸Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic
🇺🇸Ottawa, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Illinois CancerCare-Pekin
🇺🇸Pekin, Illinois, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Illinois CancerCare-Peru
🇺🇸Peru, Illinois, United States
Valley Radiation Oncology
🇺🇸Peru, Illinois, United States
Illinois CancerCare-Princeton
🇺🇸Princeton, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Springfield Memorial Hospital
🇺🇸Springfield, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Illinois CancerCare - Washington
🇺🇸Washington, Illinois, United States
Reid Health
🇺🇸Richmond, Indiana, United States
Christiana Care - Union Hospital
🇺🇸Elkton, Maryland, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital
🇺🇸Grand Rapids, Michigan, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Minnesota Oncology - Burnsville
🇺🇸Burnsville, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
🇺🇸Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Monticello Cancer Center
🇺🇸Monticello, Minnesota, United States
New Ulm Medical Center
🇺🇸New Ulm, Minnesota, United States
Fairview Northland Medical Center
🇺🇸Princeton, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Fairview Lakes Medical Center
🇺🇸Wyoming, Minnesota, United States
Parkland Health Center - Farmington
🇺🇸Farmington, Missouri, United States
Mercy Hospital South
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital
🇺🇸Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Missouri Baptist Sullivan Hospital
🇺🇸Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
🇺🇸Sunset Hills, Missouri, United States
Comprehensive Cancer Centers of Nevada - Henderson
🇺🇸Henderson, Nevada, United States
OptumCare Cancer Care at Seven Hills
🇺🇸Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
🇺🇸Henderson, Nevada, United States
Urology Specialists of Nevada - Green Valley
🇺🇸Henderson, Nevada, United States
OptumCare Cancer Care at Charleston
🇺🇸Las Vegas, Nevada, United States
Urology Specialists of Nevada - Southwest
🇺🇸Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
🇺🇸Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView
🇺🇸Las Vegas, Nevada, United States
Urology Specialists of Nevada - Northwest
🇺🇸Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
🇺🇸Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
🇺🇸Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
🇺🇸Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
🇺🇸Las Vegas, Nevada, United States
Northwell Health/Center for Advanced Medicine
🇺🇸Lake Success, New York, United States
Indu and Raj Soin Medical Center
🇺🇸Beavercreek, Ohio, United States
Strecker Cancer Center-Belpre
🇺🇸Belpre, Ohio, United States
Saint Elizabeth Boardman Hospital
🇺🇸Boardman, Ohio, United States
Oncology Hematology Care Inc-Kenwood
🇺🇸Cincinnati, Ohio, United States
Dayton Physician LLC - Englewood
🇺🇸Dayton, Ohio, United States
Armes Family Cancer Center
🇺🇸Findlay, Ohio, United States
Blanchard Valley Hospital
🇺🇸Findlay, Ohio, United States
Dayton Physicians LLC-Atrium
🇺🇸Franklin, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Greater Dayton Cancer Center
🇺🇸Kettering, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Dayton Physicians LLC - Troy
🇺🇸Troy, Ohio, United States
Saint Joseph Warren Hospital
🇺🇸Warren, Ohio, United States
Saint Elizabeth Youngstown Hospital
🇺🇸Youngstown, Ohio, United States
Providence Newberg Medical Center
🇺🇸Newberg, Oregon, United States
Providence Willamette Falls Medical Center
🇺🇸Oregon City, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
Saint Joseph's/Candler - Bluffton Campus
🇺🇸Bluffton, South Carolina, United States
Gibbs Cancer Center-Gaffney
🇺🇸Gaffney, South Carolina, United States
Prisma Health Cancer Institute - Butternut
🇺🇸Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
🇺🇸Greer, South Carolina, United States
South Carolina Cancer Specialists PC
🇺🇸Hilton Head Island, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
SMC Center for Hematology Oncology Union
🇺🇸Union, South Carolina, United States
VCU Community Memorial Health Center
🇺🇸South Hill, Virginia, United States
Shenandoah Oncology PC
🇺🇸Winchester, Virginia, United States
PeaceHealth Saint Joseph Medical Center
🇺🇸Bellingham, Washington, United States
PeaceHealth Saint John Medical Center
🇺🇸Longview, Washington, United States
Valley Medical Center
🇺🇸Renton, Washington, United States
PeaceHealth Southwest Medical Center
🇺🇸Vancouver, Washington, United States
ThedaCare Regional Cancer Center
🇺🇸Appleton, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
🇺🇸Burlington, Wisconsin, United States
Aurora Saint Luke's South Shore
🇺🇸Cudahy, Wisconsin, United States
HSHS Sacred Heart Hospital
🇺🇸Eau Claire, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
🇺🇸Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center
🇺🇸Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
🇺🇸Grafton, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
🇺🇸Green Bay, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Aurora Health Center - Greenfield
🇺🇸Greenfield, Wisconsin, United States
Aurora Cancer Care-Kenosha South
🇺🇸Kenosha, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
🇺🇸Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield
🇺🇸Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
🇺🇸Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin
🇺🇸New Richmond, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
🇺🇸Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
🇺🇸Racine, Wisconsin, United States
Marshfield Medical Center-Rice Lake
🇺🇸Rice Lake, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
🇺🇸Sheboygan, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
🇺🇸Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit
🇺🇸Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
🇺🇸Two Rivers, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
🇺🇸Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
Marshfield Medical Center - Weston
🇺🇸Weston, Wisconsin, United States