RECRUITING

LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia

Quick Facts

Study Start:2023-12-04
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06073431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer
  2. * Note: Patients do not need to have cachexia to be eligible
  3. * 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.
  4. * 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
  5. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  6. * Be able to understand, speak and read English
  7. * Be 18 years of age or older
  1. * 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
  2. * Have any planned major surgeries within the next 3 months
  3. * Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer
  4. * Be pregnant

Contacts and Locations

Principal Investigator

Richard F Dunne
PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base

Study Locations (Sites)

Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
United States
The Women's Imaging Center
Denver, Colorado, 80209
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
United States
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
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
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
Northside Hospital
Atlanta, Georgia, 30342
United States
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
United States
John B Amos Cancer Center
Columbus, Georgia, 31904
United States
Northside Hospital - Duluth
Duluth, Georgia, 30096
United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
United States
The Longstreet Clinic - Gainesville
Gainesville, Georgia, 30501
United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
United States
Tift Regional Medical Center
Tifton, Georgia, 31794
United States
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
United States
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
United States
SIH Cancer Institute
Carterville, Illinois, 62918
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Advocate Sherman Hospital
Elgin, Illinois, 60123
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
United States
Condell Memorial Hospital
Libertyville, Illinois, 60048
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
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
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
United States
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Valley Radiation Oncology
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
Reid Health
Richmond, Indiana, 47374
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
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
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
New Ulm Medical Center
New Ulm, Minnesota, 56073
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
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
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Ridgeview Medical Center
Waconia, Minnesota, 55387
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
Lake Regional Hospital
Osage Beach, Missouri, 65065
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Mercy Hospital South
St Louis, Missouri, 63128
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
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
United States
Lenox Hill Hospital
New York, New York, 10075
United States
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606
United States
Highland Hospital
Rochester, New York, 14620
United States
Pluta Cancer Center
Rochester, New York, 14623
United States
University of Rochester
Rochester, New York, 14642
United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580
United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Armes Family Cancer Center
Findlay, Ohio, 45840
United States
Blanchard Valley Hospital
Findlay, Ohio, 45840
United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
United States
Wayne Hospital
Greenville, Ohio, 45331
United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
Marietta Memorial Hospital
Marietta, Ohio, 45750
United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373
United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484
United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621
United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
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
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970
United States
Shenandoah Oncology PC
Winchester, Virginia, 22601
United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
United States
Valley Medical Center
Renton, Washington, 98055
United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
United States
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
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
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
United States
Aurora Health Center - Greenfield
Greenfield, Wisconsin, 53228
United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097
United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211
United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405
United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
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
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Richard F Dunne, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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