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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: Clinical Trial study, sponsored by Indiana University.
NCT02580422 is a clinical trial that was terminated before completion, run by Indiana University. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Changes are significant if they are \> 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2017-10-26 |
Why NCT02580422 stopped before completion
NCT02580422 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02580422 does not publish any study locations in the registry export this page uses.
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.
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