QOL and Sarcopenia in Patients With Ascites

Recruiting now

Conditions studied: Ascites Hepatic, Ascites, Malignant

In brief

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.

Key facts

Study ID

NCT05726747

Run by

Abramson Cancer Center at Penn Medicine

People needed

70

Starts

2023-05-23

Expected to finish

2027-10-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/=18
• Eastern Cooperative Oncology Group (ECOG) performance score < 3
• Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
• Capable of giving informed consent

You may not qualify if…

• Life expectancy less than 3 months
• Unable to participate in neuropsychological tests/questionnaires
• Pregnant or nursing women. .

Where it is running

• University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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