UPCC 22222 Health-related quality of life outcomes and changes in sarcopenia in patients with refractory ascites

Investigating Quality of Life and Sarcopenia in Patients with Refractory Ascites

Enrolling By Invitation
18 years or above
All
Phase N/A
70 participants needed
1 Location

Brief description of 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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ascites Hepatic, Ascites, Malignant
  • Age: 18 years or above
  • Gender: All

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. .

This study investigates the impact of refractory ascites on health-related quality of life and sarcopenia. The purpose of this study is to use new survey tools to measure changes in quality of life for patients with this condition.

Participants will complete quality of life questionnaires at the start of the study, and then again at 1, 2, 4, and 6 months. Additionally, sarcopenia, which is the loss of muscle mass and strength, will be assessed using CT scans at specific intervals. These assessments aim to provide a better understanding of how refractory ascites affects patients over time.

  • Who can participate: Adults aged 18 and older with refractory ascites due to cirrhosis or cancer, who require more than one paracentesis in a 6-week period, are eligible. Participants must have an ECOG performance score less than 3 and be able to give informed consent.
  • Study details: Participants will need to complete quality of life surveys and undergo CT scans to assess muscle mass at specified times during the study. These activities are designed to gather data on how the condition affects their health over time.
Updated on 15 Jun 2026. Study ID: 23-0052
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator