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NCT03606317 Clinical Trial

Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients

Cachexia Clinical Trial

Official title:
Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03606317
Other study ID # STU 092013-028
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 26, 2013
Est. completion date March 18, 2025

Study information
Verified date April 2024
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective is to perform a retrospective chart review of patients with cachexia related to cancer in patients treated at UT Southwestern Medical Center and Parkland Hospital to evaluate the prognosis and practice patterns in management of cachexia and associated symptoms.

Description:

The definition of cachexia has not been fully elucidated, but there are many similar parameters and guidelines associated with identifying patients with cachexia. Cachexia is a clinical diagnosis associated with weight loss, decreased muscle mass (sarcopenia), decreased strength, fatigue, and an increased inflammatory state. Patients with cachexia have a poorer prognosis than patients who have maintained their weight. Also, patients who have lost weight prior to initiating definitive therapy have worse side effects from subsequent therapy. This study involves no treatment or invasive procedures. The chart review will attempt to characterize lung and gastrointestinal cancer related cachexia in the setting of a palliative care clinic including both primary treatment and treatment at the time of recurrence. Interventions in cachectic patients for weight control including nutritional support and supplements, pain control, anti-inflammatory medications, and appetite stimulants will be tracked along with clinical markers including weight and laboratory values.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20000
Est. completion date March 18, 2025
Est. primary completion date March 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: Medical charts representing patients with a diagnosis of lung or gastrointestinal cancer with a tissue diagnosis from 1/1/2005 and onward treated at UT Southwestern or Parkland. Exclusion Criteria: There will be no absolute exclusion criteria as long as the inclusion criteria have been met.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Parkland Health and Hospital System

Outcome
Type Measure Description Time frame Safety issue
Primary Prognosis and practice patterns in the management of cachexia and its associated symptoms. This study involves no treatment or invasive procedures. The chart review will attempt to characterize lung and gastrointestinal cancer related cachexia including both primary treatment and treatment at the time of recurrence. Interventions in cachectic patients for weight control including nutritional support and supplements, pain control, anti-inflammatory medications, and appetite stimulants will be tracked along with clinical markers, including weight and laboratory values. 10 years
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