Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

About this study

Not suitable: no more information is needed to be described.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVOZAC Calming Skin Spray

Other

EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day

Physiological Saline

Other

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 outcomes

Lesion counts in total face at completion of the study period (week 4)

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Feb 8, 2012
Registry last updated: Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed