A randomized, controlled trial, comparing oral bilastine and oral hydroxyzine for treatment of pruritus in advanced solid cancer patient treated with epidermal growth factor receptor inhibitors
Phase 3
- Conditions
- advanced solid cancer patient treated with epidermal growth factor receptor inhibitorswho have prurituspruritusitchepidermal growth factor receptor inhibitorsEGFR inhibitorsbilastinehydroxyzineH1-antihistaminenon-
- Registration Number
- TCTR20170929004
- Lead Sponsor
- n/a
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
1. advanced solid cancer patient treated with epidermal growth factor receptor inhibitors
(erlotinib or gefitinib or afatinib or cetuximab)
who have pruritus CTCAE version 4.0 equal or more than grade 2
2. age more than 18 years old
Exclusion Criteria
1. other skin diseases ex. urticaria rash, eczema, psoriasis
2. use topical corticosteroids within 1 week
3. use systemicl antihistamines within 1 week
4. use systemic corticosteroids or immunotherapy within 3 weeks
5. impaired liver function
6. psychiatruc problems
7. allergy to antihistamines
8.pregnancy
9. arrhythmias
10. immunodeficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief of Pruritus at 0 weeks. 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks visual analog scale (VAS) for efficacy
- Secondary Outcome Measures
Name Time Method degree of sleepiness (side effect form intervention) at 0 weeks. 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks visual analog scale (VAS) for degree of sleepiness