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NCT02580422 · ClinicalTrials.gov registry record

Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia

A clinical trial, sponsored by Indiana University.

Terminated
Registry status
8
Enrollment target

NCT02580422 is a clinical trial that was terminated before completion, run by Indiana University. The registered enrollment target is 8 participants.

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The verdict

NCT02580422 was terminated before completion, sponsored by Indiana University.

TERMINATED
Registry status
8 participants
Enrollment target

Study Summary

Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Preclinical studies demonstrated diaphragmatic muscle wasting(29) and left ventricular wasting and fibrosis associated with mouse cachexia models.(40) Many patients, who experience cancer cachexia, describe a generalized debility and a sense of breathlessness(41) despite adequate oxygenation in the peripheral blood as measured by pulse oximetry. Whether this is related to deconditioning associated with chemotherapy or related to direct effect on cardiac and diaphragmatic muscles remains unknown. In this pilot study, the investigators propose to perform a preliminary evaluation of the cardiopulmonary function in patients with pancreatic cancer, who are likely to develop cachexia, to assess for the feasibility of performing a larger prospective study to understand the impact of cancer cachexia on cardiopulmonary function. This pilot study will provide the foundation to potentially identify cachexia in early stages (pre-cachexia) to develop pharmacological or exercise based interventions to prevent or delay its progression. Based on clinical experience and published literature, it is expected that 60-70% of patients will have \>10% weight loss during the course of this disease. More commonly, this is associated with clinical or radiographic disease progression, but certainly it can happen throughout the course of the disease even without disease progression.

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2015-10-01
Est. Completion 2017-10-26

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT02580422

The ClinicalTrials.gov registry entry for NCT02580422 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02580422 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02580422 about?

NCT02580422 is a clinical study titled "Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia". Cachexia is a systemic catabolic syndrome with apparent effect on skeletal muscles, tolerance to chemotherapy, early toxicity and quality of life; however, its effect on cardiopulmonary function is not well understood. Preclinical studies demonstrated diaphragmatic muscle wasting(29) and left ventri...

What is the current status of trial NCT02580422?

This trial is currently terminated. The enrollment target is 8 participants. The study started on 2015-10-01. Estimated completion is 2017-10-26.

Who is sponsoring clinical trial NCT02580422?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.