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LOTUS-CC: Understanding Cancer Cachexia in Advanced Cancers

This observational study, called LOTUS-CC, aims to better understand cancer cachexia (pronounced ka-KEK-see-uh), which is weight and muscle loss due to cancer. It focuses on patients with advanced colorectal, lung, or pancreatic cancer that cannot be surgically removed. Researchers will collect blood and tumor samples, review medical records, have participants wear a device to track activity, and perform physical function tests. The goal is to identify different types of cachexia to help develop more effective treatments in the future. You don't need to have cachexia to join, but you should be planning to start first-line cancer treatment within six weeks or have recently started.

Study design
This is an observational study planning to enroll 800 participants. It aims to identify different types of cancer cachexia.
What's involved
You would provide blood and archived tumor samples, undergo CT or PET/CT scans, have your medical records reviewed, wear an actigraph, and complete physical function tests. This will occur at baseline and during follow-up for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed up to one year after study completion to track changes over time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06073431

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

Recruiting
Not specifiedAges 18+Observational
University of Rochester
~800 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyElectronic Health Record ReviewMedical Device Usage and EvaluationPhysical Performance TestingPositron Emission Tomography

At a glance

Recruiting sites
196 of 225 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)
Measured over Baseline through study completion, assessed up to 1 year follow up

Conditions

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

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Adenocarcinoma

Where it's being run

225 sites across 22 states
Illinois43
Wisconsin39
Minnesota21
Nevada16
Ohio15
Colorado14
Georgia11
Hawaii10

Study leadership

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

Who to contact

Site Public Contact
800-378-9373
Do you actually qualify for this trial?

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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

What this trial measures

  • Identification of multiple distinct diagnostic subtypes within the syndrome of cancer cachexia (CC)Baseline through study completion, assessed up to 1 year follow up

    Defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers including hemoglobin and albumin, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for CC. First, will examine the distributions of each variable and assess the need for using transformations to achieve normality for continuous variables (log transformation, quartiles, or clinically important thresholds), collapsing similar variables into single categories, and excluding conditions that are too rare (\< 1% of the cohort). Next, will assess statistical correlations using the Jaccard similarity metric for binary variables and the Pearson or Spearman correlation for continuous variables to determine highly correlated variables that may provide redundant information.