Clinical trial · Observational
Pilot Project for Cardiopulmonary and Functional Evaluation in Patients With Pancreatic Cancer Associated Cachexia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The number of patients who have changes in echocardiography, pulmonary function or one or more part of their functional evaluation tests
- timeFrame
- Baseline to disease progression or development of cachexia (approximately 6 months)
- description
- Changes are significant if they are \> 15% from baseline. Development of cachexia is defined by ≥ 10% of weight loss from baseline.
Secondary outcomes (8)
- measure
- Change in pulmonary function
- timeFrame
- Baseline to disease progression or development of cachexia (approximately 6 months)
- description
- Measured by comparing scores (maximal expiratory pressure \[MEP\] and maximal inspiratory pressure \[MIP\]) from forced spirometry with folow volume loop test.
- measure
- Change in strain echocardiogram
- timeFrame
- Baseline to disease progression or development of cachexia (approximately 6 months)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with locally advanced, metastatic or recurrent pancreatic ductal adenocarcinoma (PDAC) 2. Patients who are being treated and/or followed at Indiana University Simon Cancer Center or Eskenazi Hospital 3. ECOG PS 0-2 at the time of study enrollment 4. Life expectancy \> 6 months 5. 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 6. Willingness to sign informed consent and to perform pulmonary function tests (PFTs) and strain echocardiogram Exclusion Criteria: 1. Known history of congestive heart failure (NYHA class III or IV) 2. Reported weight loss more than 10% within 3 months prior to study entry 3. Known history of pulmonary disease such as pulmonary hypertension, chronic obstructive pulmonary disease requiring medical management or previous lung resection 4. Current liver cirrhosis 5. Current chronic kidney disease 6. Inability or refusal to receive systemic therapy 7. Inability to comply with pulmonary function tests (PFTs) 8. Large volume ascites interfering with ability of respiration 9. Current unstable angina (or history of within last 6 months) 10. Recent myocardial infraction (within last 6 months) 11. Recent pneumothorax (within last 6 months) 12. Uncontrolled hypertension (per investigator's discretion) 13. Lung biopsy within one week from PFT 14. Recent surgery \< 4 weeks
References
Publications (3)
- BACKGROUNDRoberts 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
- BACKGROUNDMuhlfeld 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
- BACKGROUNDCoats 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