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

Recruiting now

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06073431

Run by

University of Rochester

People needed

800

Starts

2023-12-04

Expected to finish

2028-09-30

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States (enrolling)
• Queen's Cancer Center - Kuakini — Honolulu, Hawaii, United States (enrolling)
• Northeast Georgia Medical Center-Gainesville — Gainesville, Georgia, United States (enrolling)
• Memorial Health University Medical Center — Savannah, Georgia, United States (enrolling)
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States (enrolling)
• Straub Clinic and Hospital — Honolulu, Hawaii, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• Northside Hospital - Duluth — Duluth, Georgia, United States (enrolling)
• The Longstreet Clinic - Gainesville — Gainesville, Georgia, United States (enrolling)
• Northside Hospital - Gwinnett — Lawrenceville, Georgia, United States (enrolling)
• Tift Regional Medical Center — Tifton, Georgia, United States (enrolling)
• South Georgia Medical Center/Pearlman Cancer Center — Valdosta, Georgia, United States (enrolling)
• Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States (enrolling)
• Queen's Medical Center — Honolulu, Hawaii, United States (enrolling)
• Beebe South Coastal Health Campus — Millville, Delaware, United States (enrolling)
• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States (enrolling)
• Beebe Health Campus — Rehoboth Beach, Delaware, United States (enrolling)
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Northeast Georgia Medical Center Braselton — Braselton, Georgia, United States (enrolling)
• John B Amos Cancer Center — Columbus, Georgia, United States (enrolling)
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (enrolling)

Full record on ClinicalTrials.gov

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