Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects
Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects
1 other identifier
interventional
90
1 country
1
Brief Summary
The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2014
CompletedFirst Posted
Study publicly available on registry
November 5, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 23, 2018
April 1, 2018
1.7 years
November 3, 2014
April 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate the response rate of EGF ointment
The effectiveness of the EGF ointment was defined as follows: 1. Grade 2, 3, or 4 ERSEs downgraded to ≤Grade 1 or 2. Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.
1 year
Secondary Outcomes (1)
Quality of Life
1 year
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo ointment dose not contain EGF.
Arm EGF ointment 1ppm
ACTIVE COMPARATORArm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration
Arm EGF ointment 20ppm
ACTIVE COMPARATORArm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration
Interventions
EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day
Eligibility Criteria
You may qualify if:
- Age: older than 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Histologically confirmed lung cancer, pancreatic cancer, or colon cancer
- Patients take EGFR inhibitor following the reason
- EGFR mutation (+) NSCLC - adenocarcinoma for 1st line treatment
- NSCLC - for ≥ 2nd line treatment
- Pancreatic cancer - adenocarcinoma for 1st line treatment with Gemcitabine
- Colon cancer - adenocarcinoma 1st line treatment with Irinotecan (FOLFIRI)
- Patients who have EGFR inhibitor related skin side effects (ERSE) Gr≥2 (NCICTC V4.0)
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
You may not qualify if:
- A patient with previous active or passive immunotherapy
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
- A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications
- A patient with history of dermatologic care (except transient urticaria) within 4 weeks
- A patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months
- A patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
- Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sung Yong Oh
Busan, 602-715, South Korea
Related Publications (1)
Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
PMID: 31492766DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SUNG YONG OH, M.D.
Dong-A University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Internal Medicine, Dong-A University Hospital
Study Record Dates
First Submitted
November 3, 2014
First Posted
November 5, 2014
Study Start
April 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
April 23, 2018
Record last verified: 2018-04