Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
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:
- 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:
- 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
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:
|
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:
|
Placebo Comparator: Arm II (Study I) Patients apply placebo topically to face BID for 4 weeks. |
Other: Placebo
Given topically
Other Names:
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:
Procedure: Management of Therapy Complications
Moisturizer given topically
Other: Questionnaire Administration
Ancillary studies
Drug: Sunscreen
Given topically
Other Names:
Drug: Therapeutic Hydrocortisone
Given topically
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
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.- RC09C8
- NCI-2012-01275
- RC09C8
- P30CA015083
- NCT02257086
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
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%
|
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%
|
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%
|
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 |
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%
|
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 |
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 |
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 |
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
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 |
jatoi.aminah@mayo.edu |
- RC09C8
- NCI-2012-01275
- RC09C8
- P30CA015083
- NCT02257086