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LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
NCT06073431 · View on ClinicalTrials.gov ↗
Study 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) 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Medical Device Usage and Evaluation
- OTHER Electronic Health Record Review
- OTHER Physical Performance Testing
Study Locations (20)
Colorado
- Rocky Mountain Cancer Centers-Aurora — Aurora
- Boulder Community Foothills Hospital — Boulder
- Rocky Mountain Cancer Centers-Boulder — Boulder
- Rocky Mountain Cancer Centers - Centennial — Centennial
- The Women's Imaging Center — Denver
- Colorado Blood Cancer Institute — Denver
- Rocky Mountain Cancer Centers-Midtown — Denver
- Rocky Mountain Cancer Centers-Rose — Denver
- Rocky Mountain Cancer Centers - Swedish — Englewood
- The Melanoma and Skin Cancer Institute — Englewood
- Rocky Mountain Cancer Centers-Lakewood — Lakewood
- Rocky Mountain Cancer Centers-Littleton — Littleton
- Rocky Mountain Cancer Centers-Sky Ridge — Lone Tree
- Rocky Mountain Cancer Centers-Thornton — Thornton
Delaware
- Beebe South Coastal Health Campus — Millville
- Helen F Graham Cancer Center — Newark
- Medical Oncology Hematology Consultants PA — Newark
- Christiana Care Health System-Christiana Hospital — Newark
- Beebe Health Campus — Rehoboth Beach
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2028-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06073431
The ClinicalTrials.gov registry entry for NCT06073431 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06073431 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Colorado, Delaware, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06073431 about?
NCT06073431 is a clinical study titled "LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia". 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 de...
What is the current status of trial NCT06073431?
This trial is currently recruiting. The enrollment target is 800 participants. The study started on 2023-12-04. Estimated completion is 2028-09-30.
What conditions does trial NCT06073431 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Advanced Lung Non-Small Cell Carcinoma, Advanced Colorectal Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06073431?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Medical Device Usage and Evaluation (OTHER), Electronic Health Record Review (OTHER), Physical Performance Testing (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06073431?
This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06073431 being conducted?
This trial has 20 study locations across Arkansas, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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