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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).
The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03.
The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo ointment dose not contain EGF. |
|
| Arm EGF ointment 1ppm | Active Comparator | Arm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration |
|
| Arm EGF ointment 20ppm | Active Comparator | Arm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm EGF ointment 1ppm | Drug | EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day |
|
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the response rate of EGF ointment | The effectiveness of the EGF ointment was defined as follows:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16) | 1 year |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SUNG YONG OH, M.D. | Dong-A University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sung Yong Oh | Busan | 602-715 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31492766 | Derived | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Arm EGF ointment 20 ppm | Drug | EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day |
|
|
| Arm Placebos | Drug | EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day |
|
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |