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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01528488
First received: February 3, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Other: EVOZAC Calming Skin Spray
Other: Physiological saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Lesion counts in total face at completion of the study period (week 4) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVOZAC
EVOZAC should be sprayed to the skin of the total face three times per day.
Other: EVOZAC Calming Skin Spray
EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day
Placebo Comparator: Physiological saline
Physiological saline should be sprayed to the total face three times per day.
Other: Physiological 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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528488

Locations
China, Guangdong
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: li zhang, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Li Zhang, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01528488     History of Changes
Other Study ID Numbers: EVOZAC20110210
Study First Received: February 3, 2012
Last Updated: November 4, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2014