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This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with advanced cancer receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
I. 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)
I. 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)
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
spironolactone, placebo, questionnaire administration, sunscreen, management of therapy complications, doxycycline, therapeutic hydrocortisone
Mayo Clinic Hospital
Active, not recruiting
Academic and Community Cancer Research United
Published on BioPortfolio: 2015-03-18T03:23:23-0400
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