Clinical trial NCT05726747: QOL and Sarcopenia in Patients With Ascites
Official title: Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ascites Hepatic
Ascites, Malignant
Keywords: ascites
sarcopenia
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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).

Brief 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.

Detailed 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.

Eligibility criteria: 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. .

Primary outcomes:
measure: Health-Related Quality of Life scores as measured by the PROMIS-10 questionnaire
timeFrame: 6 months
measure: Sarcopenia as measured by psoas, paraspinal, and total abdominal wall muscle areas
timeFrame: 6 months
Secondary outcomes:
measure: Ascites-specific QOL scores as measured by the Ascites Q for patients with cirrhotic ascites.
timeFrame: 6 months
measure: Ascites-specific QOL scores as measured by the Edmonton Symptom Assessment System: Ascites Modification for patients with malignant ascites,
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Soulen, MD
role: PRINCIPAL_INVESTIGATOR
References: