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

Primary Purpose

Acneiform Rash, Papulopustular Eruption

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acneiform Rash

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Triamcinolone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

% 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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 15, 2017
Last Updated
May 13, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03115567
Brief Title
A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption
Official Title
A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment accrual
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acneiform Rash, Papulopustular Eruption

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Triamcinolone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
Primary Outcome Measure Information:
Title
% of Participants With Grade 2 Rash or Higher
Description
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
Secondary Outcome Measure Information:
Title
Change in Quality of Life Using FACT-EGFRI 18 Quality of Life Assessment
Description
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
Title
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
Description
This measure is to determine if the control group discontinues their chemotherapy regimen more often than the treatment group
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer N Choi, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20145956
Citation
Lacouture ME, Maitland ML, Segaert S, Setser A, Baran R, Fox LP, Epstein JB, Barasch A, Einhorn L, Wagner L, West DP, Rapoport BL, Kris MG, Basch E, Eaby B, Kurtin S, Olsen EA, Chen A, Dancey JE, Trotti A. A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity study group. Support Care Cancer. 2010 Apr;18(4):509-22. doi: 10.1007/s00520-009-0744-x. Epub 2010 Feb 10.
Results Reference
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A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption

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