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NCT Number: NCT05726747

QOL and Sarcopenia in Patients With 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.

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Key information

Conditions

Ascites Hepatic Ascites Ascites, Malignant Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Matthew Hung, MD

CONTACT

[email protected]

631-258-3849

About this 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Quality of Life surveys

Diagnostic Test

QoL and sarcopenia assessments

Other names: Abdominal CT

Primary outcomes

  1. Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire

    Time frame: 6 months

    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.

  2. Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas

    Time frame: 6 months

    assessed by a limited CT scan of the abdomen at the level of L4. Cross-sectional muscle area is measured.

Secondary outcomes

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    11 questions on a 0-10 scale, total score range 0-110 with higher score reflecting worse symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Thomas, MS

CONTACT

[email protected]

215-746-0352

Michael C Soulen, MD

CONTACT

[email protected]

2154218647

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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