QOL and Sarcopenia in Patients With Ascites

NCT05726747 | Recruiting

• 1 other identifier: UPCC 22222
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ascites Hepatic; Ascites, Malignant

Keywords

ascites; sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ascites-specific QOL scores as measured by the Ascites Q for patients with cirrhotic ascites.

  6 months

• Ascites-specific QOL scores as measured by the Edmonton Symptom Assessment System: Ascites Modification for patients with malignant ascites,

  6 months

Interventions

Quality of Life surveys DIAGNOSTIC_TEST

QoL and sarcopenia assessments

Also known as: Abdominal CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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. .

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Ascites; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Michael Soulen, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C Soulen, MD

CONTACT

2154218647; michael.soulen@pennmedicine.upenn.edu

Kathleen Thomas, MS

CONTACT

215-746-0352; kathleen.thomas@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Interventional Oncology

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 14, 2023
• Study Start: May 23, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)