Clinical trial NCT06073431: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
Official title: Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-10
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, colorectal cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)
timeFrame: Baseline through study completion, assessed up to 1 year follow up
Secondary outcomes:
measure: Association of each CC phenotype (clusters) with overall survival
timeFrame: Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
measure: Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente
timeFrame: Up to study completion, assessed up to 1 year
Other outcomes:
Locations:
city: Ft. Smith
country: United States
facility: Mercy Hospital Fort Smith
state: Arkansas
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers-Aurora
state: Colorado
city: Boulder
country: United States
facility: Boulder Community Foothills Hospital
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers-Boulder
state: Colorado
city: Centennial
country: United States
facility: Rocky Mountain Cancer Centers - Centennial
state: Colorado
city: Denver
country: United States
facility: The Women's Imaging Center
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers-Midtown
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers-Rose
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Cancer Centers - Swedish
state: Colorado
city: Englewood
country: United States
facility: The Melanoma and Skin Cancer Institute
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers-Lakewood
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers-Littleton
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers-Sky Ridge
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers-Thornton
state: Colorado
city: Millville
country: United States
facility: Beebe South Coastal Health Campus
state: Delaware
city: Newark
country: United States
facility: Helen F Graham Cancer Center
state: Delaware
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants PA
state: Delaware
city: Newark
country: United States
facility: Christiana Care Health System-Christiana Hospital
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Wilmington
country: United States
facility: Christiana Care Health System-Wilmington Hospital
state: Delaware
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Braselton
country: United States
facility: Northeast Georgia Medical Center Braselton
state: Georgia
city: Columbus
country: United States
facility: John B Amos Cancer Center
state: Georgia
city: Duluth
country: United States
facility: Northside Hospital - Duluth
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center-Gainesville
state: Georgia
city: Gainesville
country: United States
facility: The Longstreet Clinic - Gainesville
state: Georgia
city: Lawrenceville
country: United States
facility: Northside Hospital - Gwinnett
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
state: Georgia
city: Tifton
country: United States
facility: Tift Regional Medical Center
state: Georgia
city: Valdosta
country: United States
facility: South Georgia Medical Center/Pearlman Cancer Center
state: Georgia
city: Aiea
country: United States
facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: Aiea
country: United States
facility: Queen's Cancer Center - Pearlridge
state: Hawaii
city: Ewa Beach
country: United States
facility: The Queen's Medical Center - West Oahu
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Cenrer - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Barrington
country: United States
facility: Advocate Good Shepherd Hospital
state: Illinois
city: Bloomington
country: United States
facility: Illinois CancerCare-Bloomington
state: Illinois
city: Canton
country: United States
facility: Illinois CancerCare-Canton
state: Illinois
city: Carbondale
country: United States
facility: Memorial Hospital of Carbondale
state: Illinois
city: Carterville
country: United States
facility: SIH Cancer Institute
state: Illinois
city: Carthage
country: United States
facility: Illinois CancerCare-Carthage
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Crystal Lake
country: United States
facility: AMG Crystal Lake - Oncology
state: Illinois
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Dixon
country: United States
facility: Illinois CancerCare-Dixon
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Elgin
country: United States
facility: Advocate Sherman Hospital
state: Illinois
city: Eureka
country: United States
facility: Illinois CancerCare-Eureka
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare-Galesburg
state: Illinois
city: Hazel Crest
country: United States
facility: Advocate South Suburban Hospital
state: Illinois
city: Kewanee
country: United States
facility: Illinois CancerCare-Kewanee Clinic
state: Illinois
city: Libertyville
country: United States
facility: AMG Libertyville - Oncology
state: Illinois
city: Libertyville
country: United States
facility: Condell Memorial Hospital
state: Illinois
city: Macomb
country: United States
facility: Illinois CancerCare-Macomb
state: Illinois
city: Normal
country: United States
facility: Carle BroMenn Medical Center
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: O'Fallon
country: United States
facility: HSHS Saint Elizabeth's Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Outpatient Center - Oak Lawn
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare-Ottawa Clinic
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare-Pekin
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peru
country: United States
facility: Illinois CancerCare-Peru
state: Illinois
city: Peru
country: United States
facility: Valley Radiation Oncology
state: Illinois
city: Princeton
country: United States
facility: Illinois CancerCare-Princeton
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Springfield Memorial Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Washington
country: United States
facility: Illinois CancerCare - Washington
state: Illinois
city: Richmond
country: United States
facility: Reid Health
state: Indiana
city: Elkton
country: United States
facility: Christiana Care - Union Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Corewell Health Grand Rapids Hospitals - Butterworth Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Trinity Health Grand Rapids Hospital
state: Michigan
city: Iron Mountain
country: United States
facility: Dickinson County Healthcare System
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Maple Grove
country: United States
facility: Fairview Clinics and Surgery Center Maple Grove
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: Farmington
country: United States
facility: Parkland Health Center - Farmington
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Sainte Genevieve
country: United States
facility: Sainte Genevieve County Memorial Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Sullivan
country: United States
facility: Missouri Baptist Sullivan Hospital
state: Missouri
city: Sunset Hills
country: United States
facility: BJC Outpatient Center at Sunset Hills
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada - Henderson
state: Nevada
city: Henderson
country: United States
facility: OptumCare Cancer Care at Seven Hills
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada-Southeast Henderson
state: Nevada
city: Henderson
country: United States
facility: Urology Specialists of Nevada - Green Valley
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Charleston
state: Nevada
city: Las Vegas
country: United States
facility: Urology Specialists of Nevada - Southwest
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Northwest
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at MountainView
state: Nevada
city: Las Vegas
country: United States
facility: Urology Specialists of Nevada - Northwest
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Town Center
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada-Summerlin
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Fort Apache
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Central Valley
state: Nevada
city: Lake Success
country: United States
facility: Northwell Health/Center for Advanced Medicine
state: New York
city: Beavercreek
country: United States
facility: Indu and Raj Soin Medical Center
state: Ohio
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Boardman
country: United States
facility: Saint Elizabeth Boardman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc-Kenwood
state: Ohio
city: Dayton
country: United States
facility: Dayton Physician LLC - Englewood
state: Ohio
city: Findlay
country: United States
facility: Armes Family Cancer Center
state: Ohio
city: Findlay
country: United States
facility: Blanchard Valley Hospital
state: Ohio
city: Franklin
country: United States
facility: Dayton Physicians LLC-Atrium
state: Ohio
city: Greenville
country: United States
facility: Wayne Hospital
state: Ohio
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Troy
country: United States
facility: Dayton Physicians LLC - Troy
state: Ohio
city: Warren
country: United States
facility: Saint Joseph Warren Hospital
state: Ohio
city: Youngstown
country: United States
facility: Saint Elizabeth Youngstown Hospital
state: Ohio
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Oregon City
country: United States
facility: Providence Willamette Falls Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Bluffton
country: United States
facility: Saint Joseph's/Candler - Bluffton Campus
state: South Carolina
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Hilton Head Island
country: United States
facility: South Carolina Cancer Specialists PC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: SMC Center for Hematology Oncology Union
state: South Carolina
city: South Hill
country: United States
facility: VCU Community Memorial Health Center
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology PC
state: Virginia
city: Bellingham
country: United States
facility: PeaceHealth Saint Joseph Medical Center
state: Washington
city: Longview
country: United States
facility: PeaceHealth Saint John Medical Center
state: Washington
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical Center
state: Washington
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Burlington
country: United States
facility: Aurora Cancer Care-Southern Lakes VLCC
state: Wisconsin
city: Cudahy
country: United States
facility: Aurora Saint Luke's South Shore
state: Wisconsin
city: Eau Claire
country: United States
facility: HSHS Sacred Heart Hospital
state: Wisconsin
city: Eau Claire
country: United States
facility: Marshfield Medical Center-EC Cancer Center
state: Wisconsin
city: Germantown
country: United States
facility: Aurora Health Care Germantown Health Center
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Cancer Care-Grafton
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Saint Mary's
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Greenfield
country: United States
facility: Aurora Health Center - Greenfield
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: Marinette
country: United States
facility: Aurora Bay Area Medical Group-Marinette
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center-Marshfield
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cancer Care-Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Medical Center - Minocqua
state: Wisconsin
city: New Richmond
country: United States
facility: Cancer Center of Western Wisconsin
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic - Oshkosh
state: Wisconsin
city: Racine
country: United States
facility: Aurora Cancer Care-Racine
state: Wisconsin
city: Rice Lake
country: United States
facility: Marshfield Medical Center-Rice Lake
state: Wisconsin
city: Sheboygan
country: United States
facility: Vince Lombardi Cancer Clinic-Sheboygan
state: Wisconsin
city: Stevens Point
country: United States
facility: Marshfield Medical Center-River Region at Stevens Point
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center in Summit
state: Wisconsin
city: Two Rivers
country: United States
facility: Vince Lombardi Cancer Clinic-Two Rivers
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Cancer Care-Milwaukee West
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Richard F Dunne, MD
role: PRINCIPAL_INVESTIGATOR
References: