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

Information source: Centre Oscar Lambret
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Stage Cancer in Palliative Care

Intervention: Spironolactone (+/- Furosemide) (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Centre Oscar Lambret

Official(s) and/or principal investigator(s):
Vincent GAMBLIN, MD, Principal Investigator, Affiliation: Centre Oscar Lambret

Overall contact:
Aurélie THENOT-MARICOURT, Clinical Project Leader, Phone: +33(0)3 20 29 59 18, Email: a-thenotmaricourt@o-lambret.fr

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.

Clinical Details

Official title: A Randomized Cross-over Trial Evaluating the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Palliative Stage of Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time between symptomatic malignant ascites episodes requiring paracentesis

Secondary outcome:

Tolerance

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

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

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

Description of the patterns of prescription of diuretics

Predictive factors of response to diuretics : Serum Ascites Albumin Gradient (SAAG)

Predictive factors of response to diuretics : renin aldosterone plasmatic level

Predictive factors of response to diuretics : SAAG

Predictive factors of response to diuretics : renin aldosterone plasmatic level

Predictive factors of response to diuretics : SAAG

Predictive factors of response to diuretics : renin aldosterone plasmatic level

Predictive factors of response to diuretics : SAAG

Predictive factors of response to diuretics : renin aldosterone plasmatic level

Detailed description: Patients eligible for the trial and having signed their consent to participate will be randomized to arm A or B.

- 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with advanced stage cancer

- In exclusive palliative care (chemotherapy, hormone therapy not allowed)

- 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

Locations and Contacts

Aurélie THENOT-MARICOURT, Clinical Project Leader, Phone: +33(0)3 20 29 59 18, Email: a-thenotmaricourt@o-lambret.fr

Centre Hospitalier Intercommunal Compiègne-Noyon, Compiègne 60321, France; Not yet recruiting
Laurence BIRKUI DE FRANCQUEVILLE, MD, Email: l.birkuidefrancqueville@ch-compiegnenoyon.fr
Anne Lucile SCHULZ, MD
Laurence BIRKUI DE FRANCQUEVILLE, MD, Principal Investigator
Anne Lucile SCHULZ, MD, Sub-Investigator

Polyclinique de Grande Synthe, Grande Synthe 59760, France; Not yet recruiting
François WUYDIN, MD, Email: f.wuydin@sfr.fr
Jean-François JEU, MD
François WUYDIN, MD, Principal Investigator
Jean-François JEU, MD, Sub-Investigator

Centre Oscar Lambret, Lille 59020, France; Not yet recruiting
Vincent GAMBLIN, MD, Email: v-gamblin@o-lambret.fr
Vincent GAMBLIN, MD, Principal Investigator
Arlette DA SILVA, MD, Sub-Investigator
Stéphanie VILLET, MD, Sub-Investigator

Hôpital Saint Vincent de Paul, Lille 59000, France; Not yet recruiting
Marie DANEL, MD, Email: delerue.marie@ghicl.net
Marie DANEL, MD, Principal Investigator
Romain CHICQUET, MD, Sub-Investigator
Claudine JAUD, MD, Sub-Investigator

GH Diaconesses Croix St Simon, Paris 75571, France; Not yet recruiting
Stéphane PICARD, MD, Email: spicard@hopital-dcss.org
Stéphane PICARD, MD, Principal Investigator
Laure COPEL, MD, Sub-Investigator
Odile MARTINET, MD, Sub-Investigator
Georges CZAPIUK, MD, Sub-Investigator
Dominique KAROUI, MD, Sub-Investigator

Hôpital Jean Jaurès, Paris 75019, France; Not yet recruiting
Julia REVNIC, MD, Email: julia.revnic@hopitaljeanjaures.fr
Julia REVNIC, MD, Principal Investigator
Alix BONNIERES, MD, Sub-Investigator
Sandrine MARSAN, MD, Sub-Investigator
Elisabeth ALLOT, MD, Sub-Investigator
Amélie GEORGEON, MD, Sub-Investigator
Pascale HAOND, MD, Sub-Investigator
Estelle DESTREE, MD, Sub-Investigator

Institut Curie, Paris 75005, France; Not yet recruiting
Jean DANIS, MD, Email: jean.danis@curie.fr
Jean DANIS, MD, Principal Investigator
Carole BOULEUC, MD, Sub-Investigator
Evelyne REYNAULT TESSIER, MD, Sub-Investigator
Alexis BURNOD, MD, Sub-Investigator

Hôpital Lyon Sud, Pierre-Bénite 69495, France; Not yet recruiting
Marilène FILBET, MD, PhD, Email: marilene.filbet@chu-lyon.fr
Marilène FILBET, MD, PhD, Principal Investigator
Elise PERCEAU, MD, Sub-Investigator
Cécile BARBARET, MD, Sub-Investigator
Mathilde LEDOUX, MD, Sub-Investigator
Virginie DESSUS-CHEVREL, MD, Sub-Investigator
Mélanie PERRON, MD, Sub-Investigator

Institut Jean Godinot, Reims 51726, France; Not yet recruiting
Olivier DUBROEUCQ, MD, Email: Olivier.DUBROEUCQ@reims.unicancer.fr
Olivier DUBROEUCQ, MD, Principal Investigator
Stéphane PERIN, MD, Sub-Investigator
Philippe GUILBERT, MD, Sub-Investigator
Vivien CECCATO, MD, Sub-Investigator

Centre Hospitalier Roubaix, Roubaix 59056, France; Not yet recruiting
Katia HEBBAR, MD, Email: katia.hebbar@ch-roubaix.fr
Céline AFCHAIN, MD
Katia HEBBAR, MD, Principal Investigator
Céline AFCHAIN, MD, Sub-Investigator

Centre Paul Strauss, Strasbourg 67065, France; Not yet recruiting
Véronique FRASIE, MD, Email: vfrasie@strasbourg.unicancer.fr
Jean Michel FRASIE, MD
Véronique FRASIE, MD, Principal Investigator
Jean Michel FRASIE, MD, Sub-Investigator

Centre Hospitalier Tourcoing, Tourcoing 59200, France; Not yet recruiting
Guillaume BOUQUET, MD, Email: gbouquet@ch-tourcoing.fr
Guillaume BOUQUET, MD, Principal Investigator
Sophie FLIPO, MD, Sub-Investigator
Thérèse SAPIN, MD, Sub-Investigator

Institut Gustave Roussy, Villejuif 94805, France; Not yet recruiting
Laurence VIGOURET-VIANT, MD, Email: laurence.vigouret-viant@gustaveroussy.fr
Laurence VIGOURET-VIANT, MD, Principal Investigator
Sabine VOISIN-SALTIEL, MD, Sub-Investigator
Marie Emmanuelle GERAUD, MD, Sub-Investigator

Additional Information

Starting date: December 2015
Last updated: July 15, 2015

Page last updated: August 23, 2015

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