Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03606317
Collaborator
Parkland Health and Hospital System (Other)
20,000
111.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients
    Actual Study Start Date :
    Nov 26, 2013
    Anticipated Primary Completion Date :
    Mar 18, 2023
    Anticipated Study Completion Date :
    Mar 18, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Prognosis and practice patterns in the management of cachexia and its associated symptoms. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center
    • Parkland Health and Hospital System

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Puneeth Iyengar, Assistant Professor, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT03606317
    Other Study ID Numbers:
    • STU 092013-028
    First Posted:
    Jul 30, 2018
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Puneeth Iyengar, Assistant Professor, University of Texas Southwestern Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2022