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

Pancreatic Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Primary Objective:

To assess the feasibility of performing a prospective cardiopulmonary and physical function assessment in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are expected to develop cachexia.

Secondary Objectives:

1. To measure the changes in maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) in patients with progressive PDAC and/or cancer associated cachexia

2. To measure changes in strain echocardiography in patients with progressive PDAC and/or cancer associated cachexia

3. To assess functional changes in patients with progressive PDAC and/or cancer associated cachexia

4. To assess body composition changes associated with cachexia or disease progression

5. To measure the levels of cytokines from peripheral blood in patients with cachexia

Procedures:

All study procedures will be done at two time points (T1=baseline or study entry, T2=at disease progression or development of cachexia). Patients will undergo echocardiography with strain evaluation at Indiana University Health Echocardiography Laboratory and pulmonary function tests as per institutional guidelines at IUH PFT laboratory at University Hospital. Patients will also have 20mL (2 red top tubes) of blood drawn for the studies outlined in Section 7.5. Standard of care labs will be taken from the patient's medical records. Patients also will be evaluated using three standardized functional assessment tools commonly utilized in physical rehabilitation: 1) 5 Times Sit-to-Stand Test; 2) 6 Minute Walk Test; and 3) grip dynamometry. Standard of care CT scan obtained at the time of tumor assessment will enable the investigators to assess body muscle mass as described in Section 7.4. In addition, the investigators will administer three standardized survey tools to assess quality of life and prior level of function: 1) The Short Form 36 (SF-36); 2) Lower Extremity Functional Scale (LEFS); and 3) Scored Patient-Generated Subjective Global Assessment (PG-SGA).

Sample Size:

Due to the risk of clinical deterioration or drop out of the study and inability to undergo T2 evaluation, the investigators will plan on enrolling 133% of desired number of subjects, accounting for 33% missing T2 data. This is likely a high number; however, this will enable data collection from 12-15 patients at both time points and all proposed tests. ;

Related Conditions & MeSH terms

• Cachexia
• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT02580422
• Study type: Observational
• Source: Indiana University
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2015
• Completion date: October 26, 2017