Status:
RECRUITING
LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Colorectal Carcinoma
Advanced Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
18+ years
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 r...
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, blo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06073431
Start Date
December 4 2023
End Date
September 30 2028
Last Update
January 9 2026
Active Locations (225)
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1
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
2
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
3
Boulder Community Foothills Hospital
Boulder, Colorado, United States, 80303
4
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304