A Phase 2 interventional study of Spironolactone (+/- Furosemide) in Cancer, sponsored by Centre Oscar Lambret. Terminated at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by Centre Oscar Lambret · Phase 2, Interventional, and Treatment
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.
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 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.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's enrollment of 14 is below the median of 55 across 177 interventional studies indexed under Ascites.
Browse Ascites studies →Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical monitoring and best supportive care.
Diuretics (spironolactone +/- Furosemide) are administered the day after the paracentesis and until the next episode requiring paracentesis.
Drug: 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.
Also known as: Spiroctan, Aldactone
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.
Tolerance
Adverse events and serious adverse events related to diuretic treatment according to NCI-CTCAE v4.0
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the end of the study (up to 6 months).
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.
Time frame: 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).
Predictive factors of response to diuretics : Serum Ascites Albumin Gradient (SAAG)
Time frame: Within 24 hours prior to the start of treatment
Predictive factors of response to diuretics : renin aldosterone plasmatic level
Time frame: Within 24 hours prior to the start of treatment
Predictive factors of response to diuretics : SAAG
Time frame: Twice a week for patients randomized in arm B
Predictive factors of response to diuretics : renin aldosterone plasmatic level
Time frame: Twice a week for patients randomized in arm B
Predictive factors of response to diuretics : SAAG
Time frame: At cross-over (approximately 15 days after inclusion)
Predictive factors of response to diuretics : renin aldosterone plasmatic level
Time frame: At cross-over (approximately 15 days after inclusion)
Predictive factors of response to diuretics : SAAG
Time frame: At the end of the study (up to 6 months).
Predictive factors of response to diuretics : renin aldosterone plasmatic level
Time frame: At the end of the study (up to 6 months).
Plan to share: No
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This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Centre Oscar Lambret