This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
150mg po daily
topical, daily for 30 days.
topical, daily for 30 days.
topical, daily for 30 days
Unnamed facility
Fortaleza, Ceará, Brazil
Unnamed facility
Fortaleza, Ceará, Brazil
Unnamed facility
Salvador, Estado de Bahia, Brazil
Unnamed facility
Salvador, Estado de Bahia, Brazil
Unnamed facility
Salvador, Estado de Bahia, Brazil
Unnamed facility
Taguatinga, Federal District, Brazil
Unnamed facility
Goiânia, Goiás, Brazil
Unnamed facility
Belo Horizonte, Minas Gerais, Brazil
Unnamed facility
Belo Horizonte, Minas Gerais, Brazil
Unnamed facility
Divinópolis, Minas Gerais, Brazil
...and 16 more locations
Percentage of Participants Who Develop Skin Rash
Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").
Time frame: 30 Days
Percentage of Participants With Skin Rash Stratified by Severity Grade
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death
Time frame: 30 Days
Time to Appearance of Skin Rash
Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE
Time frame: Days 0, 15, and 30
Percentage of Participants With Erythema
Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries
Time frame: Days 0, 15, and 30
Percentage of Participants With Pruritus
Pruritus is defined as intense localized itching
Time frame: Days 0, 15, and 30
Percentage of Participants With Pain
Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli
Time frame: Days 0, 15, and 30
Percentage of Participants With Erythema Stratified by Severity Grade
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Time frame: 30 Days
Percentage of Participants With Pruritus Stratified by Severity Grade
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Time frame: 30 Days
Percentage of Participants With Pain Stratified by Severity Grade
The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Time frame: 30 Days
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