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

ConditionsAdvanced Colorectal CarcinomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Pancreatic AdenocarcinomaStage IV Colorectal Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Unresectable Colorectal CarcinomaUnresectable Lung Non-Small Cell CarcinomaUnresectable Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, colorectal cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and archived tumor samples

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT scan

  • Electronic Health Record Review

    Other intervention

    Medical records reviewed

  • Medical Device Usage and Evaluation

    Other intervention

    Wear actigraph

  • Physical Performance Testing

    Other intervention

    Undergo physical function tests

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT scan

  • Survey Administration

    Other intervention

    Complete surveys

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Observational (survey, function tests, biospecimen, actigraph)7 interventions

Trial outcomes

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.

Time frame
Baseline through study completion, assessed up to 1 year follow up

Secondary outcomes

1

Association of each CC phenotype (clusters) with overall survival

Will be assessed in the Cox regression model. Will estimate the bivariate association where the only independent variables will be the indicators for the cluster membership. Will report the hazard ratio for the association of each CC phenotype, specifying the lowest-risk cluster as the reference. Will assess the influence of selected factors (e.g., age, performance status, and other known prognostic factors) on the association of the cluster with survival by adding the factor to the model as a covariate and keeping those that resulted in 10% or more change in any regression coefficients for cluster membership. Will assess if the association of clusters with survival varies by specific subgroups (e.g., older versus younger age, gender, and cancer type). Will assess the statistical significance interaction of the subgroup with the cluster membership by maximum likelihood test and evaluate the regression coefficients for clusters in each subgroup comparing the direction and magnitude.

Time frame
Days from registration (day 0) to death (the event) or the last contact (censored), assessed up to 1 year follow up
2

Validation of CC diagnostic phenotypes developed in a separate, independent cachexia observational study performed by collaborators at Kaiser Permanente

Study participants will be categorized into the Kaiser Permanente Northern California (KPNC)-derived CC phenotype groups. Will use the final latent class analysis model fit in the KPNC data to compute the posterior probabilities of membership in each latent class for each individual National Cancer Institute Community Oncology Research Program (NCORP) participant based on his/her individual data. Will compare cluster prevalence in each cohort as well as the distributions of the variables used to determine each cluster to investigate patterns of commonality and dissimilarity across the contributing variables. Validation will be determined by fitting University of Rochester Cancer Center (URCC) NCORP participants in KPNC-derived clusters and evaluating each cluster's association with survival. If the ranking of survival (best to worst) among each cluster in the URCC NCORP dataset mirrors the prognostic ranking of clusters in the KPNC dataset, the clusters will be deemed validated.

Time frame
Up to study completion, assessed up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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