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AzTrials

CancerPhase 2NCT02501213

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

A Phase 2 study testing Spironolactone (+/- Furosemide) in people with Cancer, run by Centre Oscar Lambret at 15 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Spironolactone (+/- Furosemide)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
15 sitesFrance
Study dates
30 May 2016to 24 Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Centre Hospitalier Intercommunal Compiègne-Noyon

    Compiègne, 60321

  • Polyclinique de Grande Synthe

    Grande-Synthe, 59760

  • CHRU Lille

    Lille, 59000

  • Hôpital Saint Vincent de Paul

    Lille, 59000

  • Centre Oscar Lambret

    Lille, 59020

  • Institut Curie

    Paris, 75005

  • Hôpital Jean Jaurès

    Paris, 75019

  • GH Diaconesses Croix St Simon

    Paris, 75571

  • Hôpital Lyon Sud

    Pierre-Bénite, 69495

  • Institut Jean Godinot

    Reims, 51726

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Paul Strauss

    Strasbourg, 67065

  • Centre Hospitalier Tourcoing

    Tourcoing, 59200

  • Polyclinique Vauban

    Valenciennes, 59300

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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

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.

Read the 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
Being tested
Spironolactone (+/- Furosemide)
Keywords
Diuretic, Malignant ascites
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spironolactone (+/- Furosemide)Drug

    Also called Spiroctan, Aldactone

    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.

Study groups in NCT02501213
Study groupRoleWhat they receive
A : observationNo interventionClinical monitoring and best supportive care.
B : diureticsActive comparatorDiuretics (spironolactone +/- Furosemide) are administered the day after the paracentesis and until the next episode requiring paracentesis.
Receives: Drug: Spironolactone (+/- Furosemide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time between symptomatic malignant ascites episodes requiring paracentesis

    Measured: Patients will be followed until their third malignant ascites episode, an expected average of 30 days.

Secondary outcomes (13)

  1. Tolerance

    Adverse events and serious adverse events related to diuretic treatment according to NCI-CTCAE v4.0

    Measured: Up to 30 days after the last administration of the product

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

    Measured: At baseline (prior to the start of treatment)

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

    Measured: At cross-over (approximately 15 days after inclusion)

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

    Measured: At the end of the study (up to 6 months).

  5. Description of the patterns of prescription of diuretics

    Growth pattern doses of diuretics, decrement pattern doses of diuretics, maintenance doses of diuretics, maximum doses reached of diuretics.

    Measured: 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).

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

    Measured: Within 24 hours prior to the start of treatment

  7. Predictive factors of response to diuretics : renin aldosterone plasmatic level

    Measured: Within 24 hours prior to the start of treatment

  8. Predictive factors of response to diuretics : SAAG

    Measured: Twice a week for patients randomized in arm B

  9. Predictive factors of response to diuretics : renin aldosterone plasmatic level

    Measured: Twice a week for patients randomized in arm B

  10. Predictive factors of response to diuretics : SAAG

    Measured: At cross-over (approximately 15 days after inclusion)

  11. Predictive factors of response to diuretics : renin aldosterone plasmatic level

    Measured: At cross-over (approximately 15 days after inclusion)

  12. Predictive factors of response to diuretics : SAAG

    Measured: At the end of the study (up to 6 months).

  13. Predictive factors of response to diuretics : renin aldosterone plasmatic level

    Measured: At the end of the study (up to 6 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2015 (estimated)
  2. Study start30 May 2016
  3. Primary completion23 Nov 2017
  4. Study completion24 Dec 2018

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501213
Sponsor's protocol ID
DIASC-1507
Status last verified
May 2019
First submitted
2 Jul 2015
Last updated
16 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Spironolactone (+/- Furosemide) in people with Cancer, run by Centre Oscar Lambret at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time between symptomatic malignant ascites episodes requiring paracentesis (time frame: Patients will be followed until their third malignant ascites episode, an expected average of 30 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02501213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.

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