RecruitingNCT05726747

QOL and Sarcopenia in Patients With Ascites

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

70 participants

Start Date

May 23, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTQuality of Life surveys

QoL and sarcopenia assessments


Locations(1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05726747


Related Trials