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

NCT02501213 | Terminated Phase 2 DMC

• 1 other identifier: DIASC-1507
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 15

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.

Conditions

Cancer

Keywords

Diuretic; Malignant ascites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Tolerance

  Up to 30 days after the last administration of the product

• Quality of life based on the EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15-PAL

  At baseline (prior to the start of treatment)

• Quality of life based on the EORTC (European Organization for Research and Treatment of Cancer) QLQ-C15-PAL

  At cross-over (approximately 15 days after inclusion)

• 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).

• 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).

Study Arms (2)

A : observation

NO INTERVENTION

Clinical monitoring and best supportive care.

B : diuretics

ACTIVE COMPARATOR

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

Drug: Spironolactone (+/- Furosemide)

Interventions

Spironolactone (+/- Furosemide) 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.

Also known as: Spiroctan, Aldactone

B : diuretics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• National Cancer Institute, France: collaborator

Study Sites (15)

Centre Hospitalier Intercommunal Compiègne-Noyon

Compiègne, 60321, France

Location

Polyclinique de Grande Synthe

Grande-Synthe, 59760, France

Location

CHRU Lille

Lille, 59000, France

Location

Hôpital Saint Vincent de Paul

Lille, 59000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Jean Jaurès

Paris, 75019, France

Location

GH Diaconesses Croix St Simon

Paris, 75571, France

Location

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51726, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Hospitalier Tourcoing

Tourcoing, 59200, France

Location

Polyclinique Vauban

Valenciennes, 59300, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Spironolactone; Furosemide; Canrenoic Acid

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pregnadienes

Study Officials

• Vincent GAMBLIN, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 17, 2015
• Study Start: May 30, 2016
• Primary Completion: November 23, 2017
• Study Completion: December 24, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)