Non-small Cell Lung Cancer
Conditions
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.
Interventions
OTHEREVOZAC Calming Skin Spray
EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day
OTHERPhysiological saline
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
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion counts in total face at completion of the study period (week 4) | 12 months |
Countries
China
Outcome results
None listed