Clinical trial · Interventional
Evaluation of the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Stage of Cancer (DIASC)
A Randomized Cross-over Trial Evaluating the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Palliative Stage of Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spironolactone (+/- Furosemide) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A : observation
- description
- Clinical monitoring and best supportive care.
- type
- ACTIVE_COMPARATOR
- label
- B : diuretics
- description
- Diuretics (spironolactone +/- Furosemide) are administered the day after the paracentesis and until the next episode requiring paracentesis.
- interventionNames
- Drug: Spironolactone (+/- Furosemide)
Primary outcomes (1)
- measure
- Time between symptomatic malignant ascites episodes requiring paracentesis
- timeFrame
- Patients will be followed until their third malignant ascites episode, an expected average of 30 days.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced stage cancer * First episode of malignant ascites * Grade 2 or 3 ascites * Clinically symptomatic ascites requiring paracentesis due to : abdominal pain or heaviness, dyspnoea, orthopnoea, nausea/vomiting, anorexia, early satiety, gastro-oesophageal reflux, lower limb and genital oedema * Age ≥ 18 years * Performance status ≤ 3 * Life expectancy ≥ 1 month * Absence of contra-indication to diuretic treatment * Patient regularly followed up by a palliative care or supportive care team * Signed and dated informed consent Exclusion Criteria: * Hepatic disorders : cirrhosis, hepatitis, hepatocellular insufficiency, hepatic encephalopathy * Non malignant ascites * Hydroelectrolytic disorders: hyponatremia (\< 130 mmol/L) or hyperkaliemia (\> 5 mmol/L) or severe hypokaliemia (\< 3 mmol/L) * Functional acute renal insufficiency * Urinary disorders : Obstruction in the urinary tract, Oliguria/anuria * Chronic renal failure * Patient unable to swallow * Sulfamides allergy * Hypersensitivity to spironolactone or to any of the excipients * Hypersensitivity to furosemide or to any of the excipients * Pregnant or breastfeeding women * Patient under guardianship
References
Publications (0)
Data not yet available