Study of the Effect of Eplerenone on Heart Function in Women Receiving Anthracycline Chemotherapy for Breast Cancer

NCT01708798

Last updated date
Study Location
British Columbia Cancer Agency, Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Stage I-III breast cancer

- Scheduled to undergo treatment with doxorubicin-based chemotherapy regimen

- Able to provide informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Use of anthracycline agents other than doxorubicin


- Baseline LVEF ≤50% by any modality (nuclear, echo, MRI)


- Atrial fibrillation or flutter


- Mitral valve disease (More than mild mitral stenosis or regurgitation, previous mitral
valve replacement or repair)


- Inability to obtain adequate echo images for required analysis


- Hyperkalemia (K+ >5.0)


- Glomerular filtration rate (GFR) <30 ml/min/1.73m2


- Uncontrolled hypertension, defined as having a systolic blood pressure > 180 mmHg
and/or a diastolic blood pressure >110 mmHg


- Symptomatic hypotension or systolic blood pressure <85 mmHg


- History of hypersensitivity to eplerenone or spironolactone


- Significant hepatic disease (e.g., previously documented positive serology for viral
hepatitis) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
>3 times the upper limits of normal


- Concomitant treatment with spironolactone, potassium-sparing diuretics, potassium
supplements, or strong inhibitors of cytochrome P450 3A4 (CYP3A4) (i.e. ketoconazole,
itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)


- History of alcohol and/or any other drug abuse


- Women who are either pregnant, lactating or of childbearing potential and not using an
acceptable method of contraception


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation of
trial results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this trial

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of the Effect of Eplerenone on Heart Function in Women Receiving Anthracycline Chemotherapy for Breast Cancer
Official Title  ICMJE A Prospective Randomized Placebo-controlled Study of the Effect of Eplerenone on Left Ventricular Diastolic Function in Women Receiving Anthracycline Therapy for Breast Cancer
Brief Summary

Doxorubicin and other anthracyclines are commonly used to treat breast cancer and other types of cancer. Unfortunately, they can cause heart muscle damage, resulting in scarring, abnormal contraction and relaxation, and heart failure symptoms. This side effect occurs more frequently at higher doses, and limits the total dose that can be given to cancer patients. Eplerenone is an oral medication that prevents or reverses heart damage in other disease states, and is commonly used to treat heart failure. This study will investigate the use of eplerenone to protect the heart from these harmful side effects of doxorubicin.

Few therapies have been shown to prevent heart damage in patients receiving anthracyclines. Small studies have suggested that other heart failure medications (ACE inhibitors, beta-blockers) may reduce the incidence of cardiac toxicity, but eplerenone and other drugs in its class (aldosterone antagonists) have not previously been studied. Eplerenone inhibits enzyme pathways that cause scarring of the heart, and animal studies suggest that anthracyclines cause damage through these same pathways.

This study aims to investigate whether eplerenone protects the heart from the harmful effects of doxorubicin chemotherapy. Specifically, it will measure the effect that eplerenone has on heart muscle relaxation. It will randomly assign women undergoing chemotherapy with doxorubicin to one of two groups: one group will receive eplerenone, and the other group will receive placebo (sugar) pills. The subjects will not know which type of pills they are taking. Heart muscle relaxation will be measured at baseline, after completion of chemotherapy (8-12 weeks), and after 6 months. There will also be various blood tests measured in the study subjects, to determine whether there might be certain blood tests that identify patients at particularly high risk of heart toxicity after doxorubicin therapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Eplerenone
    Other Name: Inspra
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    One tablet by mouth daily. If serum potassium level is <5.0 mmol/L at four weeks, increase to two tablets by mouth daily.

    If estimated glomerular filtration rate (eGFR) is between 30-49 ml per min per 1.73m2, initial dose is: one tablet by mouth every other day. If serum potassium level is <5.0 mmol/L at four weeks, increase to one tablet by mouth daily.

    Intervention: Drug: Placebo
  • Experimental: Eplerenone

    Eplerenone 25 mg tablet by mouth daily. If serum potassium level is <5.0 mmol/L at four weeks, increase to two 25 mg tablets by mouth daily.

    If estimated glomerular filtration rate (eGFR) is between 30-49 ml per min per 1.73m2, initial dose is: eplerenone 25 mg tablet by mouth every other day. If serum potassium level is <5.0 mmol/L at four weeks, increase to 25 mg tablet by mouth daily.

    Intervention: Drug: Eplerenone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2012)
78
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage I-III breast cancer
  • Scheduled to undergo treatment with doxorubicin-based chemotherapy regimen
  • Able to provide informed consent

Exclusion Criteria:

  • Use of anthracycline agents other than doxorubicin
  • Baseline LVEF ?50% by any modality (nuclear, echo, MRI)
  • Atrial fibrillation or flutter
  • Mitral valve disease (More than mild mitral stenosis or regurgitation, previous mitral valve replacement or repair)
  • Inability to obtain adequate echo images for required analysis
  • Hyperkalemia (K+ >5.0)
  • Glomerular filtration rate (GFR) <30 ml/min/1.73m2
  • Uncontrolled hypertension, defined as having a systolic blood pressure > 180 mmHg and/or a diastolic blood pressure >110 mmHg
  • Symptomatic hypotension or systolic blood pressure <85 mmHg
  • History of hypersensitivity to eplerenone or spironolactone
  • Significant hepatic disease (e.g., previously documented positive serology for viral hepatitis) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 times the upper limits of normal
  • Concomitant treatment with spironolactone, potassium-sparing diuretics, potassium supplements, or strong inhibitors of cytochrome P450 3A4 (CYP3A4) (i.e. ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)
  • History of alcohol and/or any other drug abuse
  • Women who are either pregnant, lactating or of childbearing potential and not using an acceptable method of contraception
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01708798
Other Study ID Numbers  ICMJE H12-00185
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE
  • Canadian Cancer Society Research Institute (CCSRI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Sean A Virani, MD, MSc, MPHUniversity of British Columbia
Principal Investigator:Margot Davis, MDUniversity of British Columbia
PRS Account University of British Columbia
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP