QOL and Sarcopenia in Patients With Ascites
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Life expectancy less than 3 months
Unable to participate in neuropsychological tests/questionnaires
Pregnant or nursing women. .
Trial design
Treatments tested in this trial
- Quality of Life surveys
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov