QOL and Sarcopenia in Patients With Ascites

Recruiting

• Conditions: Ascites Hepatic; Ascites, Malignant

• Registration Number: NCT05726747
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

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 Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-14
• Study Start: 2023-05-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-04
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire	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.
Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas	6 months	assessed by a limited CT scan of the abdomen at the level of L4. Cross-sectional muscle area is measured.

Secondary Outcome Measures

Name	Time	Method
Ascites-specific QOL scores as measured by the Ascites Q for patients with cirrhotic ascites.	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.
Ascites-specific QOL scores as measured by the Edmonton Symptom Assessment System: Ascites Modification for patients with malignant ascites,	6 months	11 questions on a 0-10 scale, total score range 0-110 with higher score reflecting worse symptoms.

Trial Locations

Locations (1)

University of Pennsylvania Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States