Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients

April 25, 2023 updated by: Puneeth Iyengar, University of Texas Southwestern Medical Center
The objective is to perform a retrospective chart review of patients with cachexia related to cancer in patients treated in the palliative care clinic at Parkland Memorial Hospital to evaluate the prognosis and practice patterns in management of cachexia and associated symptoms.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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 pancreatic 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.

Study Type

Observational

Enrollment (Anticipated)

20000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects medical charts will be identified by the palliative care clinic database with diagnosis during the above time frame. Data from charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, and date of birth. These are all patients treated by all hospitals and clinics affiliated with the Parkland palliative care clinic. At the time of study, many of the patients will have expired but some will be alive and in the regional North Texas area. Thus, given the fact the majority of patients will have expired at the time of this study and the minimal risk nature of this retrospective chart review, we could not reasonably conduct this research with a full waiver of consent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognosis and practice patterns in the management of cachexia and its associated symptoms.
Time Frame: 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Parkland Health and Hospital System

Investigators

  • Principal Investigator: Puneeth Iyengar, MD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2013

Primary Completion (Anticipated)

March 18, 2025

Study Completion (Anticipated)

March 18, 2025

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 092013-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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