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

Stopped early

Conditions studied: Cachexia, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT02580422

Run by

Indiana University

People needed

8

Starts

2015-10-01

Expected to finish

2017-10-26

Last updated by the study team

2018-02-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• As defined by the following laboratory values at study entry:
• Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
• ANC ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
• Total bilirubin ≤ 1.5 x ULN
• AST/ALT ≤ 3 x ULN
• Willingness to sign informed consent and to perform pulmonary function tests (PFTs) and strain echocardiogram

You may not qualify if…

• Known history of congestive heart failure (NYHA class III or IV)
• 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
• Current unstable angina (or history of within last 6 months)
• Recent myocardial infraction (within last 6 months)
• Recent pneumothorax (within last 6 months)
• Uncontrolled hypertension (per investigator's discretion)
• Lung biopsy within one week from PFT
• Recent surgery < 4 weeks

Where it is running

• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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