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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20170929004

Enrollment

Registered

2017-09-29

Start date

2017-10-09

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid cancer patient treated with epidermal growth factor receptor inhibitors who have pruritus pruritus itch epidermal growth factor receptor inhibitors EGFR inhibitors bilastine hydroxyzine H1&#45

Interventions

bilastine 20 mg oral once daily ,hydroxyzine 10 mg oral three times a day

Experimental Drug,Experimental Drug

bilastine,hydroxyzine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactPawinee Rerknimitr

Faculty of Medicine, Chulalongkorn University

pawinee.r@chula.ac.th02-2564253

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

A randomized&#44; controlled trial&#44; comparing oral bilastine and oral hydroxyzine for treatment of pruritus in advanced solid cancer patient treated with epidermal growth factor receptor inhibitors