Assessing quality of life and muscle loss in patients with fluid buildup in the abdomen
Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites
This study is trying to see how fluid buildup in the abdomen affects the quality of life and muscle loss in patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05726747 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the quality of life in patients suffering from refractory ascites, a condition characterized by fluid accumulation in the abdomen. It will utilize newer quality of life survey instruments to gather data on both benign and malignant causes of ascites. Additionally, the study will assess sarcopenia, or muscle loss, in these patients by measuring muscle area through CT imaging at specific intervals. Data will be collected at baseline and then at 1, 2, 4, and 6 months to track changes over time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with refractory ascites due to cirrhosis or malignancy requiring frequent paracentesis.
Not a fit: Patients with a life expectancy of less than 3 months or those unable to participate in assessments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the quality of life and muscle health of patients with refractory ascites, potentially guiding future interventions.
How similar studies have performed: While there is limited data on the quality of life in this specific patient population, similar studies have shown the importance of prospective assessments in understanding patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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. .
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael Soulen, MD — University of Pennsylvania
- Study coordinator: Michael C Soulen, MD
- Email: michael.soulen@pennmedicine.upenn.edu
- Phone: 2154218647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.