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

Purpose 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 and left ventricular wasting and fibrosis associated with mouse cachexia models. Many patients, who experience cancer cachexia, describe a generalized debility and a sense of breathlessness 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.
Recruitment This study is not yet open for participant recruitment.
Condition Cachexia; Pancreatic Cancer
Intervention Not Provided
Outcome Measures
Primary Outcome Measures:
  • The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
  • Changes are significant if they are > 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.
Secondary Outcome Measures:
  • Change in pulmonary function [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing scores (maximal expiratory pressure [MEP] and maximal inspiratory pressure [MIP]) from forced spirometry with folow volume loop test.
  • Change in strain echocardiogram [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing strain echocardiograms
  • Change in self-reported quality of life [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing Short Form-36 questionnaire scores
  • Change in self-reported function via LEFS questionnaire [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing Lower Extremity Functional Scale (LEFS) questionnaire scores
  • Change in self-reported function via PG-SGA questionnaire [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing Patient-Generated Subjective Global Assessment (PG-SGA) questionnaire scores
  • Change in functional evaluation test [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing grip dynamometry, 6-minute walk test, 5-minute sit-to-stand test scores
  • Change in body composition via CT scan [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured by comparing CT scans that are analyzed using Sliceomatic (Tomovision) technology
  • Change in levels of cytokines [ Time Frame: Baseline to disease progression or development of cachexia (approximately 6 months) ] [ Designated as safety issue: No ]
    Measured through blood samples collected at each time point which are evaluated for cytokine levels using enzyme-linked immunosorbent assay (ELISA).
Locations and Contacts
Contact
Janet Flynn, RN; 317-274-0972; janflynn@iupui.edu
Melissa Stanleyl; 317-274-0335; mestanle@iupui.edu

Location
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center - Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Janet Flynn, RN 317-274-0972; janflynn@iupui.edu

Sidney & Lois Eskenazi Hospital - Not yet recruiting
Indianapolis, Indiana, United States, 46219
Contact: Janet Flynn, RN 317-274-0972; janflynn@iupui.edu


More Info clinicaltrials.gov/ct2/show/NCT02580422

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