LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
Recruiting · NCT06073431 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionComputed TomographyElectronic Health Record ReviewMedical Device Usage and EvaluationPhysical Performance TestingPositron Emission TomographySurvey Administration
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
60 locations listed across 22 US states.
- Mercy Hospital Fort Smith - Fort 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 D.C., 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 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
- 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
- OSF Saint Anthony's Health Center - Alton, Illinois, 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
Showing 60 of 225 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →