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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

800

participants targeted

Target at P75+ for all trials

Timeline

28mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach

1 country

225 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.8 years study duration

Study Progress52%

Dec 2023Sep 2028

First Submitted

Initial submission to the registry

October 3, 2023

Completed

7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2027

Expected

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

October 3, 2023

Last Update Submit

January 7, 2026

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Association of each CC phenotype (clusters) with overall survival
Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente
Up to study completion, assessed up to 1 year

Study Arms (1)

Observational (survey, function tests, biospecimen, actigraph)

Patients complete surveys over 30 minutes, undergo physical function tests over 30 minutes, undergo collection of blood and archived tumor samples, and wear actigraph over 24 hours for 7 days to record daily sleep and exercise activity at baseline and 3-month follow-up. Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.

Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Electronic Health Record ReviewOther: Medical Device Usage and EvaluationOther: Physical Performance TestingProcedure: Positron Emission TomographyOther: Survey Administration