Recruiting

Observational Study

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05726747

Conditions

Ascites Hepatic

Ascites, Malignant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality of Life surveys

Study Details

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

Study ID

NCT05726747

Start date

May 23, 2023

Status verified date

Jun, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Interventions

Quality of Life surveys

QoL and sarcopenia assessments

Primary outcome measure

  • Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire [ Time Frame: 6 months ]
  • Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Michael C Soulen, MD

2154218647michael.soulen@pennmedicine.upenn.edu

Kathleen Thomas, MS

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

Locations

University of Pennsylvania Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Matthew Hung, MD

631-258-3849matthew.hung@pennmedicine.upenn.edu

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • ascites
  • sarcopenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-15.