Cancer
URCC-22063: Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia
Description
This is a Prospective Observational Cohort Study, designed to better characterize patients with cancer cachexia (CC) by prospectively evaluating weight, muscle mass, fat mass, eating and appetite, physical function, symptoms, and associated medical and biopsychosocial factors. CC was defined by an international consensus panel as a “multifactorial syndrome characterized by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment1.” CC has been associated with reduced physical performance, impaired quality of life and poorer survival. Unfortunately, there currently are no Food and Drug Administration (FDA)-approved treatment for CC. Therefore, therapeutic development for CC is an urgent unmet need.
The diagnostic criteria for CC as defined by the international consensus are as follows: a) greater than 5% weight loss in the previous 6 months or b) greater than 2% weight loss with either low Body Mass Index (BMI) or skeletal muscle depletion. A key criticism of the diagnostic criteria is that it is too broad and simplistic for a complex, multifactorial disease process and that it relies too heavily on weight, which is subject to change from a myriad of conditions. The aim of this study will be to develop new diagnostic criteria for CC subtypes so that pathophysiologic drivers of CC can be isolated in individuals and, ultimately, more tailored therapies can be developed.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
Eligibility Criteria
Patients must:
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, RT) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible.
Have an ECOG performance status of 0, 1 or 2.
Be able to understand, speak and read English.
Be 18 years of age or older.
Start Date
Thursday, October 3, 2024
Principal / Contact Name
Mark A. Taylor, MD