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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
United States
Pennsylvania
University of Pennsylvania Perelman School of Medicine
RECRUITING
Philadelphia
Contact Information
Primary
Michael C Soulen, MD
michael.soulen@pennmedicine.upenn.edu
2154218647
Backup
Kathleen Thomas, MS
kathleen.thomas@pennmedicine.upenn.edu
215-746-0352
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-10
Participants
Target number of participants: 70
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center at Penn Medicine

This content was sourced from clinicaltrials.gov

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