This randomized, controlled, phase II clinical study is designed to assess the efficacy of preemptive treatment with topical steroids in preventing the papulopustular eruption induced by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients. Participants will be followed up for 6 weeks of twice daily application of triamcinolone cream to the face, chest, and back.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
14
6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States
% of Participants With Grade 2 Rash or Higher
To assess the difference in percentage of participants who develop a grade 2 or greater rash in the control group as compared to the case group of preemptive treatment with topical steroids (triamcinolone 0.1% cream for application to face, chest and back) when administered concomitantly for 6 weeks with erlotinib, cetuximab, panitumumab, or afatinib to prevent papulopustular eruptions.
Time frame: 6 weeks
Change in Quality of Life Using FACT-EGFRI 18 Quality of Life Assessment
To assess the difference in change in quality-of-life due to rash at Visit 4 from Visit 1 between the two treatment groups. FACT-EGFRI 18 is an 18-question assessment for cancer patients undergoing EGFR treatment. The scoring range is 0-72, with 72 indicating more severe functional impact.
Time frame: 6 weeks
Number of Participants in the Treatment and Control Group Who Adhere to Their Chemotherapy Regimen Determined by Whether Patients Discontinue Their Chemotherapy Regimen or Continue Their Full Course of Treatment
This measure is to determine if the control group discontinues their chemotherapy regimen more often than the treatment group
Time frame: 6 weeks
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