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Retrospective Review of Palliative Care Patients With Cachexia: 2002-2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606317
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
Parkland Health and Hospital System
Information provided by (Responsible Party):
Puneeth Iyengar, University of Texas Southwestern Medical Center

Study Description
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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
Cachexia

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
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Review of Palliative Care Patients With Cachexia: 2002-2013
Actual Study Start Date : November 26, 2013
Estimated Primary Completion Date : March 18, 2023
Estimated Study Completion Date : March 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, date of birth, and social security number. 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.
Criteria

Inclusion Criteria:

Medical charts representing patients with a diagnosis of lung or 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606317


Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parkland Health and Hospital System
Investigators
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Principal Investigator: Puneeth Iyengar, MD UT Southwestern Medical Center
More Information
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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: July 30, 2018    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Puneeth Iyengar, University of Texas Southwestern Medical Center:
Lung and gastrointestinal malignancies
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Emaciation
Weight Loss
 Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders