Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
EVOZAC Calming Skin Spray
Physiological saline
Sponsored by
About this trial
This is an interventional prevention trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically proven NSCLC diagnosis
- Life expectancy over four weeks
- absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
- With normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
- Suitable for EGFR-TKIs treatment and expectant duration over four weeks
- No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
- With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTC] grade ≥ 3)
- No other concomitant therapy referred to the face skin during the study
- Signed and dated informed consent
Exclusion Criteria:
- Performance status ≥ 3(ECOG)
- Pregnant or breast-feeding patients
- The lesion counts can't be evaluated due to concomitant diseases or other conditions
- Not suitable for EGFR-TKIs treatment
Sites / Locations
- Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EVOZAC
Physiological saline
Arm Description
EVOZAC should be sprayed to the skin of the total face three times per day.
Physiological saline should be sprayed to the total face three times per day.
Outcomes
Primary Outcome Measures
Lesion counts in total face at completion of the study period (week 4)
Secondary Outcome Measures
Full Information
NCT ID
NCT01528488
First Posted
February 3, 2012
Last Updated
November 4, 2013
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01528488
Brief Title
Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC
Official Title
A Randomized, Double-blind, Prospective Trial of Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with the encouraging efficacy in NSCLC is the common side effects, of which the most common one is the specific papular and pustular acne-like rash which affects mainly the face, scalp, and upper torso. But till now, no medicament has been proved effective enough to treat or prevent the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity at the rash prevention in our preliminary study, so the investigators conduct the randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.
Detailed Description
Not suitable: no more information is needed to be described.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVOZAC
Arm Type
Experimental
Arm Description
EVOZAC should be sprayed to the skin of the total face three times per day.
Arm Title
Physiological saline
Arm Type
Placebo Comparator
Arm Description
Physiological saline should be sprayed to the total face three times per day.
Intervention Type
Other
Intervention Name(s)
EVOZAC Calming Skin Spray
Intervention Description
EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day
Intervention Type
Other
Intervention Name(s)
Physiological saline
Intervention Description
Physiological saline was used as the placebo of EVOZAC® Calming Skin Spray and should be also sprayed on the total face, three times per day
Primary Outcome Measure Information:
Title
Lesion counts in total face at completion of the study period (week 4)
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven NSCLC diagnosis
Life expectancy over four weeks
absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
With normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
Suitable for EGFR-TKIs treatment and expectant duration over four weeks
No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTC] grade ≥ 3)
No other concomitant therapy referred to the face skin during the study
Signed and dated informed consent
Exclusion Criteria:
Performance status ≥ 3(ECOG)
Pregnant or breast-feeding patients
The lesion counts can't be evaluated due to concomitant diseases or other conditions
Not suitable for EGFR-TKIs treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li zhang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC
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