A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2022-09-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Acneiform Rash Papulopustular Eruption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Patients in Control group will be instructed to follow a daily moisturizer and sunscreen regimen. Erlotinib, cetuximab, panitumumab, or afatinib will be administered as standard of care treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Triamcinolone

Patients in the Triamcinolone group will be applying Triamcinolone 0.1% cream daily to their face, chest, and upper back, in addition to adhering to the same daily moisturizer and sunscreen regimen of the Control group. Erlotinib, cetuximab, panitumumab, or afatinib will be administered concomitantly as standard of care treatment.

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.

Interventions

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Triamcinolone

6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have a histologically or cytologically confirmed cancer diagnosis for which EGFRI treatment is indicated
* Initiation of topical steroids or control treatment within 3 days of initiation of cetuximab, erlotinib, panitumumab, or afatinib
* Patients must be age ≥ 18 years.
* Life expectancy of greater than 6 weeks
* Patient able to use topical medications reliably and complete questionnaires with assistance if needed
* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Exclusion Criteria

* Patients who have used systemic or topical steroids within 7 days of trial registration, or start systemic or topical steroids for reasons unrelated to trial during the 6-week follow up period
* Patients who have used antibiotics within 7 days of trial registration, or start antibiotics for other conditions during the 6-week follow up period
* History of allergic reactions to topical steroids
* Patients with any rash at the time of study registration
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients using any other topical medications in the treatment areas (face, chest, or back).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No