QOL and Sarcopenia in Patients With Ascites

Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites

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.

Study Overview

• Status: Recruiting
• Conditions: Ascites Hepatic; Ascites, Malignant
• Intervention / Treatment: Diagnostic test: Quality of Life surveys

Detailed Description

Patients with refractory ascites defined as requiring >1 paracentesis within a 6 week period will be prospectively enrolled. The Patient-Reported Outcomes Measurement Information System (PROMIS-10) and ascites-specific (Ascites Q and Edmonton Symptom Assessment System: Ascites Modification) quality of life questionnaires will be obtained at baseline, then at 1-, 2-, 4- and 6 months. Sarcopenia will be assessed by muscle area measurement from a single CT image at the L4 level at baseline, 2- and 6 months.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Michael C Soulen, MD; Phone Number: 2154218647; Email: michael.soulen@pennmedicine.upenn.edu
• Study Contact Backup: Name: Kathleen Thomas, MS; Phone Number: 215-746-0352; Email: kathleen.thomas@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Perelman School of Medicine
      • Contact: Matthew Hung, MD; Phone Number: 631-258-3849; Email: matthew.hung@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

35-40 unique patients are seen by interventional radiology in the Perelman Center for Advanced Medicine or the Hospital of the University of Pennsylvania for a therapeutic paracentesis per month in an outpatient setting. Approximately half of these patients (~20 per month) meet criteria for refractory ascites requiring frequent large volume paracentesis (i.e. more than 1 therapeutic paracentesis in a 6 week period).

Description

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. .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire	Patient-Reported Outcomes Measurement Information System (PROMIS-10) survey scores physical and mental health on a 4-20 point scale which are combined into an overall score with higher scores reflecting better quality of life.	6 months
Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas	assessed by a limited CT scan of the abdomen at the level of L4. Cross-sectional muscle area is measured.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascites-specific QOL scores as measured by the Ascites Q for patients with cirrhotic ascites.	Ascites Q asks 11 questions on a 2-11 scale. Total is normalized to a 0-100 point scale with higher score reflecting worse symptoms.	6 months
Ascites-specific QOL scores as measured by the Edmonton Symptom Assessment System: Ascites Modification for patients with malignant ascites,	11 questions on a 0-10 scale, total score range 0-110 with higher score reflecting worse symptoms.	6 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Michael Soulen, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 24, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: sarcopenia; ascites
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia; Ascites
• Other Study ID Numbers: UPCC 22222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No