Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer As… (NCT02580422) | Clinical Trial Compass
TerminatedNot Applicable
Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia
Stopped: Low accrual
United States8 participantsStarted 2015-10-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with locally advanced, metastatic or recurrent pancreatic ductal adenocarcinoma (PDAC)
. Patients who are being treated and/or followed at Indiana University Simon Cancer Center or Eskenazi Hospital
. ECOG PS 0-2 at the time of study enrollment
. Life expectancy \> 6 months
. Adequate organ function
. Willingness to sign informed consent and to perform pulmonary function tests (PFTs) and strain echocardiogram
Exclusion criteria
. Known history of congestive heart failure (NYHA class III or IV)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests
Timeframe: Baseline to disease progression or development of cachexia (approximately 6 months)
. Reported weight loss more than 10% within 3 months prior to study entry
. Known history of pulmonary disease such as pulmonary hypertension, chronic obstructive pulmonary disease requiring medical management or previous lung resection
. Current liver cirrhosis
. Current chronic kidney disease
. Inability or refusal to receive systemic therapy
. Inability to comply with pulmonary function tests (PFTs)
. Large volume ascites interfering with ability of respiration