Evaluation of the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Stage of Cancer (DIASC)
- Registration Number
- NCT02501213
- Lead Sponsor
- Centre Oscar Lambret
- Brief 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.
- Detailed Description
Patients eligible for the trial and having signed their consent to participate will be randomized to arm A or B.
Treatment order is randomly attributed to patients at the 1st paracentesis, after the reception of the laboratory results necessary to evaluate SAAG value. Randomization is stratified 1:1 according to SAAG values (≥ or \< to 11g/L) and Systemic treatment (yes or not)
* Patients randomized to arm A will be observed until the next episode requiring paracentesis (due to clinical symptoms : abdominal pain or heaviness, dyspnoea, orthopnoea, nausea/vomiting, anorexia, early satiety, gastro-oesophageal reflux, lower limb and genital oedema), at which time they will receive arm B (diuretics), in absence of contra-indication to diuretic treatment.
* Patients randomized to arm B will receive diuretics until the next episode requiring paracentesis, at which time they will receive arm A (observation).
Patients will have a physical assessment within 24 hours prior to the start of treatment, once every two weeks for patients randomized in arm A and each week for patients randomized in arm B, at cross-over and at the end of the study. Patient will also have a biological assessment within 24 hours prior to the start of treatment, twice a week for patients randomized in arm B, at cross-over and at the end of the study. Finally, they will address a quality of life questionnaire (QLQ-C15-PAL) prior to the start of treatment, at cross-over and at the end of the study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B : diuretics Spironolactone (+/- Furosemide) Diuretics (spironolactone +/- Furosemide) are administered the day after the paracentesis and until the next episode requiring paracentesis.
- Primary Outcome Measures
Name Time Method Time between symptomatic malignant ascites episodes requiring paracentesis Patients will be followed until their third malignant ascites episode, an expected average of 30 days.
- Secondary Outcome Measures
Name Time Method Predictive factors of response to diuretics : renin aldosterone plasmatic level At the end of the study (up to 6 months). Predictive factors of response to diuretics : Serum Ascites Albumin Gradient (SAAG) Within 24 hours prior to the start of treatment Tolerance Up to 30 days after the last administration of the product Adverse events and serious adverse events related to diuretic treatment according to NCI-CTCAE v4.0
Quality of life based on the EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15-PAL At the end of the study (up to 6 months). Predictive factors of response to diuretics : SAAG At the end of the study (up to 6 months). Description of the patterns of prescription of diuretics During randomization in arm B (that is to say during approximately 15 days between the first and the second or between the second and the third milgnant ascites episode). Growth pattern doses of diuretics, decrement pattern doses of diuretics, maintenance doses of diuretics, maximum doses reached of diuretics.
Trial Locations
- Locations (15)
Centre Hospitalier Intercommunal Compiègne-Noyon
🇫🇷Compiègne, France
Polyclinique de Grande Synthe
🇫🇷Grande Synthe, France
CHRU Lille
🇫🇷Lille, France
Hôpital Saint Vincent de Paul
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut Curie
🇫🇷Paris, France
Hôpital Lyon Sud
🇫🇷Pierre-Bénite, France
Hôpital Jean Jaurès
🇫🇷Paris, France
GH Diaconesses Croix St Simon
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Hospitalier Tourcoing
🇫🇷Tourcoing, France
Polyclinique Vauban
🇫🇷Valenciennes, France
Institut Gustave Roussy
🇫🇷Villejuif, France