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

NCT02580422 | Terminated DMC

• 1 other identifier: IUSCC-0547
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cachexia; Pancreatic Cancer

Keywords

Echocardiography

Outcome Measures

Primary Outcomes (1)

• The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests

  Changes are significant if they are \> 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.

  Baseline to disease progression or development of cachexia (approximately 6 months)

Secondary Outcomes (8)

• Change in pulmonary function

  Baseline to disease progression or development of cachexia (approximately 6 months)

• Change in strain echocardiogram

  Baseline to disease progression or development of cachexia (approximately 6 months)

• Change in self-reported quality of life

  Baseline to disease progression or development of cachexia (approximately 6 months)

• Change in self-reported function via LEFS questionnaire

  Baseline to disease progression or development of cachexia (approximately 6 months)

• Change in self-reported function via PG-SGA questionnaire

  Baseline to disease progression or development of cachexia (approximately 6 months)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified from the outpatient oncology clinic at the Indiana University Health Melvin and Bren Simon Cancer Center or Sidney \& Lois Eskenazi Health Hospital.

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, 46219, United States

Location

Related Publications (3)

• Roberts BM, Ahn B, Smuder AJ, Al-Rajhi M, Gill LC, Beharry AW, Powers SK, Fuller DD, Ferreira LF, Judge AR. Diaphragm and ventilatory dysfunction during cancer cachexia. FASEB J. 2013 Jul;27(7):2600-10. doi: 10.1096/fj.12-222844. Epub 2013 Mar 20.

  PMID: 23515443 BACKGROUND

• Muhlfeld C, Das SK, Heinzel FR, Schmidt A, Post H, Schauer S, Papadakis T, Kummer W, Hoefler G. Cancer induces cardiomyocyte remodeling and hypoinnervation in the left ventricle of the mouse heart. PLoS One. 2011;6(5):e20424. doi: 10.1371/journal.pone.0020424. Epub 2011 May 26.

  PMID: 21637823 BACKGROUND

• Coats AJ. Origin of symptoms in patients with cachexia with special reference to weakness and shortness of breath. Int J Cardiol. 2002 Sep;85(1):133-9. doi: 10.1016/s0167-5273(02)00242-5.

  PMID: 12163218 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected: one sample for cytokine analysis, one sample for future research.

MeSH Terms

Conditions

Cachexia; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Safi Shahda, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: May 27, 2017
• Study Completion: October 26, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (2)