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

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

• 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood and archived tumor samples

PROCEDURE

Computed Tomography

Undergo CT or PET/CT scan

OTHER

Electronic Health Record Review

Medical records reviewed

OTHER

Medical Device Usage and Evaluation

Wear actigraph

OTHER

Physical Performance Testing

Undergo physical function tests

PROCEDURE

Positron Emission Tomography

Undergo PET/CT scan

OTHER

Survey Administration

Complete surveys

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Rochester

  lead OTHER

Principal Investigators

• Richard F Dunne · University of Rochester NCORP Research Base

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-04

Primary Completion

2027-11-13

Completion

2028-09-30

Countries

• United States

Study Locations