Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Indiana University
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
