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QOL and Sarcopenia in Patients With Ascites
Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Age \>/=18 2. Eastern Cooperative Oncology Group (ECOG) performance score \< 3 3. Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment. 4. Capable of giving informed consent Exclusion Criteria: 1. Life expectancy less than 3 months 2. Unable to participate in neuropsychological tests/questionnaires 3. Pregnant or nursing women. .
About the study
Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies.
Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites.
Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.
What is being tested
- Quality of Life surveys (diagnostic test)
Sponsor: Abramson Cancer Center at Penn Medicine · Participants: 70 · Started: May 23, 2023
Contact the study team
- Michael C Soulen, MD · Phone: 2154218647
- Kathleen Thomas, MS · Phone: 215-746-0352
Official record on ClinicalTrials.gov — NCT05726747
Locations in the U.S.
| Pennsylvania | University of Pennsylvania Perelman School of Medicine, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.