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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115567
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Nam Choi, MD, Northwestern University

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE February 16, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
% of participants with grade 2 rash or higher [ Time Frame: 6 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • Difference in rash severity using the NCI-CTCAE 4.03 grading criteria [ Time Frame: 6 weeks ]
    To assess the difference in maximum severity of rash between the preemptive treatment group and the reactive treatment group.
  • Concordance of rash grading between NCI-CTCAE and Lacouture grading scale [ Time Frame: 6 weeks ]
    To assess the concordance of rash severity grading between the NCI-CTCAE grading system (grade 1-5 ) and those of Lacouture et al. (1a, 1b, 2a, 2b, 3a,3b), and global rash severity (grade 1-3) based on photographic analysis.
  • Change in quality of life using FACT-EGFRI 18 quality of life assessment [ Time Frame: 6 weeks ]
    To assess the difference in change in quality-of-life due to rash between the two treatment groups.
  • 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 [ Time Frame: 6 weeks ]
    This measure is to determine if the control group discontinues their chemotherapy regimen more often than the treatment group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption
Official Title  ICMJE A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acneiform Rash
  • Papulopustular Eruption
Intervention  ICMJE Drug: Triamcinolone
6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
Study Arms  ICMJE
  • No Intervention: 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.
  • Experimental: 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.
    Intervention: Drug: Triamcinolone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2017)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dermatology CTU 312-503-5944 NUOncoderm@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03115567
Other Study ID Numbers  ICMJE JNC06142016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Nam Choi, MD, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer N Choi, MD Northwestern University
PRS Account Northwestern University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP