Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab

Sponsor
Academic and Community Cancer Research United (Other)
Overall Status
Completed
CT.gov ID
NCT01867294
Collaborator
National Cancer Institute (NCI) (NIH)
19
5
4
21.4
3.8
0.2

Study Details

Study Description

Brief Summary

This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine feasibility of the administration of topical spironolactone versus placebo in this patient population. (Study I) II. To further explore the efficacy of the topical spironolactone to prevent/attenuate rash from EGFR inhibitors. (Study II)
SECONDARY OBJECTIVES:
  1. To explore efficacy of the spironolactone versus placebo. (Study I) II. To describe the efficacy of a Modified Preemptive Therapy Regimen intervention. (Study II) III. To explore the adverse event profile of spironolactone and the Modified Preemptive Therapy Regimen intervention. (Study II) IV. To explore patient reported outcomes of patients using spironolactone and a Modified Preemptive Therapy Regimen intervention. (Study II) V. To explore long term (8 week) effect of the 4 week treatment of spironolactone and a Modified Preemptive Therapy Regimen intervention on EFGR induced rash. (Study II)
OUTLINE:

STUDY I: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply spironolactone topically to face twice daily (BID) for 4 weeks.

ARM II: Patients apply placebo topically to face BID for 4 weeks.

STUDY II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply spironolactone topically to face and body BID for 4 weeks

ARM II: Patients undergo modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically before going outside, hydrocortisone topically once daily (QD), and doxycycline orally (PO) BID for 4 weeks.

After completion of study, patients are followed up for 4 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
A Two-Part, Phase II Randomized Trial to Explore Topical Spironolactone to Prevent/Attenuate Rash From Epidermal Growth Factor Receptor Inhibitors (Panitumumab and Cetuximab) in Advanced Cancer Patients
Actual Study Start Date :
Aug 31, 2012
Actual Primary Completion Date :
May 9, 2014
Actual Study Completion Date :
Jun 13, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (Study I)

Patients apply spironolactone topically to face BID for 4 weeks.

Other: Questionnaire Administration
Ancillary studies

Drug: Spironolactone
Given topically
Other Names:
  • 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate
  • Aldactone
  • SC 9420
  • SPL
  • Experimental: Arm I (Study II)

    Patients apply spironolactone topically to face and body BID for 4 weeks.

    Other: Questionnaire Administration
    Ancillary studies

    Drug: Spironolactone
    Given topically
    Other Names:
  • 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate
  • Aldactone
  • SC 9420
  • SPL
  • Placebo Comparator: Arm II (Study I)

    Patients apply placebo topically to face BID for 4 weeks.

    Other: Placebo
    Given topically
    Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
  • Other: Questionnaire Administration
    Ancillary studies

    Active Comparator: Arm II (Study II)

    Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.

    Drug: Doxycycline
    Given PO
    Other Names:
  • Doxycycline Monohydrate
  • Procedure: Management of Therapy Complications
    Moisturizer given topically

    Other: Questionnaire Administration
    Ancillary studies

    Drug: Sunscreen
    Given topically
    Other Names:
  • Sunblock
  • Drug: Therapeutic Hydrocortisone
    Given topically
    Other Names:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Cortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • hydrocortisone
  • Hydrocortone
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rectoid
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I) [At 8 weeks]

      Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here.

    2. Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I) [At 4 weeks]

      Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks.

    3. Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I) [At 4 weeks]

      The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.

    4. Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II) [At 4 weeks]

      The primary analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 4. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 4 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.

    Secondary Outcome Measures

    1. Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I) [At 4 weeks]

      Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.

    2. Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II) [At 4 weeks]

      All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.

    3. Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II) [At 8 weeks]

      This analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 8. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 8 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.

    4. Incidence of Healthcare Provider Reported Adverse Events (Study II) [At 8 weeks]

      All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.

    5. Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II) [At 4 weeks]

      Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization

    • Ability to reliably apply topical spironolactone/placebo twice a day to the face

    • Ability to complete questionnaire(s) by themselves or with assistance

    • For study 2 only, patients must be willing to avoid sun exposure for one month from registration

    • Creatinine =< 1.5 x upper limit of normal (UNL)

    • For Study 2 only, ability to apply topical creams to the entire face and body

    Exclusion Criteria:
    • Prior allergic reaction or severe intolerance to spironolactone

    • Any rash at the time of randomization

    • Cutaneous metastases

    • Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist

    • Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol)

    • For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carle Cancer Center Urbana Illinois United States 61801
    2 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    3 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    4 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    5 Marshfield Clinic Marshfield Wisconsin United States 54449

    Sponsors and Collaborators

    • Academic and Community Cancer Research United
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Aminah Jatoi, Academic and Community Cancer Research United

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Academic and Community Cancer Research United
    ClinicalTrials.gov Identifier:
    NCT01867294
    Other Study ID Numbers:
    • RC09C8
    • NCI-2012-01275
    • RC09C8
    • P30CA015083
    • NCT02257086
    First Posted:
    Jun 4, 2013
    Last Update Posted:
    Jan 9, 2020
    Last Verified:
    Jan 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Study II was never opened due to the accrual rate in Study I.
    Pre-assignment Detail
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Period Title: Overall Study
    STARTED 9 10 0 0
    COMPLETED 8 9 0 0
    NOT COMPLETED 1 1 0 0

    Baseline Characteristics

    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy Total
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks. Total of all reporting groups
    Overall Participants 8 9 0 0 17
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    65.0
    60.6
    62.6
    Sex: Female, Male (Count of Participants)
    Female
    2
    25%
    2
    22.2%
    4
    Infinity
    Male
    6
    75%
    7
    77.8%
    13
    Infinity
    Region of Enrollment (participants) [Number]
    United States
    8
    100%
    9
    100%
    17
    Infinity

    Outcome Measures

    1. Primary Outcome
    Title Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
    Description Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here.
    Time Frame At 8 weeks

    Outcome Measure Data

    Analysis Population Description
    All patients that began study treatment were included in this analysis.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 8 9 0 0
    Count of Participants [Participants]
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)
    Description Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks.
    Time Frame At 4 weeks

    Outcome Measure Data

    Analysis Population Description
    All patients that began protocol treatment are included in this endpoint.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 8 9 0 0
    Count of Participants [Participants]
    6
    75%
    6
    66.7%
    3. Primary Outcome
    Title Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)
    Description The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.
    Time Frame At 4 weeks

    Outcome Measure Data

    Analysis Population Description
    All patients that began Study I treatment were included in this endpoint.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 8 0 0 0
    Count of Participants [Participants]
    4
    50%
    0
    0%
    4. Primary Outcome
    Title Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)
    Description The primary analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 4. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 4 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.
    Time Frame At 4 weeks

    Outcome Measure Data

    Analysis Population Description
    Study II was not conducted.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 0 0 0 0
    5. Secondary Outcome
    Title Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)
    Description Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.
    Time Frame At 4 weeks

    Outcome Measure Data

    Analysis Population Description
    All patients that began study treatment are included in this analysis.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 8 9 0 0
    Number [participants]
    1
    12.5%
    2
    22.2%
    6. Secondary Outcome
    Title Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)
    Description All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.
    Time Frame At 4 weeks

    Outcome Measure Data

    Analysis Population Description
    Study II was not conducted.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 0 0 0 0
    7. Secondary Outcome
    Title Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)
    Description This analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 8. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 8 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.
    Time Frame At 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Study II was not conducted.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 0 0 0 0
    8. Secondary Outcome
    Title Incidence of Healthcare Provider Reported Adverse Events (Study II)
    Description All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.
    Time Frame At 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Study II was not conducted.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 0 0 0 0
    9. Secondary Outcome
    Title Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)
    Description Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.
    Time Frame At 4 weeks

    Outcome Measure Data

    Analysis Population Description
    Study II was not conducted.
    Arm/Group Title Study I: Spironolactone Study I: Placebo Study II: Spironolactone Study II: Modified Therapy
    Arm/Group Description Patients apply spironolactone topically to face BID for 4 weeks. Patients apply placebo topically to face BID for 4 weeks. Patients apply spironolactone topically to face and body BID for 4 weeks. Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
    Measure Participants 0 0 0 0

    Adverse Events

    Time Frame Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.
    Adverse Event Reporting Description Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.
    Arm/Group Title Study I: Placebo Study I: Spironolactone
    Arm/Group Description Patients apply placebo topically to face BID for 4 weeks. .Patients apply spironolactone topically to face BID for 4 weeks.
    All Cause Mortality
    Study I: Placebo Study I: Spironolactone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/9 (22.2%) 0/8 (0%)
    Serious Adverse Events
    Study I: Placebo Study I: Spironolactone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/9 (22.2%) 2/8 (25%)
    Blood and lymphatic system disorders
    Anemia 1/9 (11.1%) 1 0/8 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 1/9 (11.1%) 1 0/8 (0%) 0
    Abdominal pain 1/9 (11.1%) 1 0/8 (0%) 0
    Ascites 1/9 (11.1%) 1 0/8 (0%) 0
    Ileus 1/9 (11.1%) 1 0/8 (0%) 0
    Mucositis oral 0/9 (0%) 0 1/8 (12.5%) 1
    General disorders
    Death NOS 1/9 (11.1%) 1 0/8 (0%) 0
    Fatigue 1/9 (11.1%) 1 0/8 (0%) 0
    Multi-organ failure 1/9 (11.1%) 1 0/8 (0%) 0
    Hepatobiliary disorders
    Hepatobiliary disorders - Other, specify 1/9 (11.1%) 1 0/8 (0%) 0
    Infections and infestations
    Sepsis 1/9 (11.1%) 1 0/8 (0%) 0
    Injury, poisoning and procedural complications
    Gastrointestinal stoma necrosis 1/9 (11.1%) 1 0/8 (0%) 0
    Intraoperative hemorrhage 1/9 (11.1%) 1 0/8 (0%) 0
    Investigations
    Blood bilirubin increased 1/9 (11.1%) 1 0/8 (0%) 0
    Creatinine increased 1/9 (11.1%) 1 0/8 (0%) 0
    INR increased 1/9 (11.1%) 1 0/8 (0%) 0
    Lymphocyte count decreased 1/9 (11.1%) 1 0/8 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 1/9 (11.1%) 1 0/8 (0%) 0
    Hyperglycemia 1/9 (11.1%) 1 0/8 (0%) 0
    Hypoalbuminemia 1/9 (11.1%) 1 0/8 (0%) 0
    Hypocalcemia 1/9 (11.1%) 1 0/8 (0%) 0
    Hypokalemia 1/9 (11.1%) 1 0/8 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 1/9 (11.1%) 1 0/8 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia 1/9 (11.1%) 1 0/8 (0%) 0
    Pulmonary edema 1/9 (11.1%) 1 0/8 (0%) 0
    Respiratory failure 1/9 (11.1%) 1 0/8 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritus 0/9 (0%) 0 1/8 (12.5%) 1
    Rash maculo-papular 0/9 (0%) 0 1/8 (12.5%) 1
    Other (Not Including Serious) Adverse Events
    Study I: Placebo Study I: Spironolactone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/9 (88.9%) 6/8 (75%)
    Blood and lymphatic system disorders
    Anemia 1/9 (11.1%) 1 0/8 (0%) 0
    Ear and labyrinth disorders
    Hearing impaired 1/9 (11.1%) 1 0/8 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/9 (11.1%) 1 0/8 (0%) 0
    Hepatobiliary disorders
    Cholecystitis 1/9 (11.1%) 1 0/8 (0%) 0
    Infections and infestations
    Sepsis 1/9 (11.1%) 1 0/8 (0%) 0
    Investigations
    Lymphocyte count decreased 2/9 (22.2%) 3 0/8 (0%) 0
    Neutrophil count decreased 0/9 (0%) 0 1/8 (12.5%) 1
    White blood cell decreased 0/9 (0%) 0 1/8 (12.5%) 1
    Metabolism and nutrition disorders
    Anorexia 1/9 (11.1%) 1 0/8 (0%) 0
    Dehydration 1/9 (11.1%) 1 0/8 (0%) 0
    Hypokalemia 0/9 (0%) 0 1/8 (12.5%) 2
    Hyponatremia 1/9 (11.1%) 1 0/8 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritus 6/9 (66.7%) 8 5/8 (62.5%) 8
    Rash maculo-papular 6/9 (66.7%) 9 6/8 (75%) 10
    Vascular disorders
    Hypotension 1/9 (11.1%) 1 0/8 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Aminah Jatoi, M.D.
    Organization Mayo Clinic
    Phone 507.284.1623
    Email jatoi.aminah@mayo.edu
    Responsible Party:
    Academic and Community Cancer Research United
    ClinicalTrials.gov Identifier:
    NCT01867294
    Other Study ID Numbers:
    • RC09C8
    • NCI-2012-01275
    • RC09C8
    • P30CA015083
    • NCT02257086
    First Posted:
    Jun 4, 2013
    Last Update Posted:
    Jan 9, 2020
    Last Verified:
    Jan 1, 2018