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
This trial does not accept healthy volunteersQualifiers
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 population
35-40 unique patients are seen by interventional radiology in the Perelman Center for Advanced Medicine or the Hospital of the University of Pennsylvania for a therapeutic paracentesis per month in an outpatient setting. Approximately half of these patients (\~20 per month) meet criteria for refractory ascites requiring frequent large volume paracentesis (i.e. more than 1 therapeutic paracentesis in a 6 week period).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quality of Life surveys
Diagnostic testQoL and sarcopenia assessments
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov