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

NCT ID: NCT02501213

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2018-12-24

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A : observation

Clinical monitoring and best supportive care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

B : diuretics

Diuretics (spironolactone +/- Furosemide) are administered the day after the paracentesis and until the next episode requiring paracentesis.

Group Type: ACTIVE_COMPARATOR

Spironolactone (+/- Furosemide)

Intervention Type: DRUG

Administration of spironolactone alone 100 mg/day each morning, increased in increments of 100 mg / week to a maximum of 400 mg / day in the absence of efficiency. In case of ineffectiveness or hyperkalemia: addition of Furosemide 40 mg / day increased in increments of 40 mg / week to a maximum of 160 mg / day in the absence of efficiency.

Interventions

Spironolactone (+/- Furosemide)

Administration of spironolactone alone 100 mg/day each morning, increased in increments of 100 mg / week to a maximum of 400 mg / day in the absence of efficiency. In case of ineffectiveness or hyperkalemia: addition of Furosemide 40 mg / day increased in increments of 40 mg / week to a maximum of 160 mg / day in the absence of efficiency.

Intervention Type: DRUG

Other Intervention Names

Spiroctan; Aldactone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent GAMBLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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 Jean Jaurès

Paris, , France

GH Diaconesses Croix St Simon

Paris, , France

Hôpital Lyon Sud

Pierre-Bénite, , 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

Countries

France

Other Identifiers

DIASC-1507

Identifier Type: -

Identifier Source: org_study_id