drugset / Trial / NCT02501213

Evaluation of the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Stage of Cancer (DIASC)

NCT02501213

RandomizedCrossoverOpen-labelTreatment

Summary

While some authors recommend diuretics as the first treatment to initiate for symptoms caused by malignant ascites (MA), their prescription is variable. No randomized, controlled study has assessed their benefit in this context. According to literature, diuretics may bring relief in about 40% of cases, regardless of primary tumor. The purpose of our study is to assess the effectiveness of diuretic treatment according to Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the time elapsed between recurrent MA that requires paracentesis. The investigators will also examine whether SAAG and serum levels of renin and aldosterone can predict symptom response to diuretics.

Timeline

Start
2016-05-30
Primary completion
2017-11-23
Completion
2018-12-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Furosemide Other / unclassified 160 mg
Comparator Spironolactone Small molecule 400 mg

Indications