QOL and Sarcopenia in Patients With Ascites

Ascites Hepatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726747
• Other study ID #: UPCC 22222
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: October 2025

Study information

• Verified date: June 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Michael C Soulen, MD
• Phone: 2154218647
• Email: michael.soulen[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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. .

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic
• Ascites, Malignant
• Sarcopenia

Intervention

Diagnostic Test:
• Quality of Life surveys
QoL and sarcopenia assessments

Locations

Country	Name	City	State
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

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