Evaluation of Esomeprazole cream effect on prevention of acute radiation dermatitis

Effectiveness and safety of Esomeprazole cream in the prevention of acute radiation dermatitis in head and neck cancer patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211029052907N1

Enrollment

Registered

2022-01-28

Start date

2022-03-21

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

acute radiation dermatitis. Acute radiodermatitis

Interventions

Intervention 1: Intervention group: Esomeprazole cream. Intervention 2: Control group: Placebo.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient with histopathologically proven diagnosis of head and neck cancer Planned to receive radiotherapy with or without chemotherapy at least 60 Grays

Exclusion criteria

Exclusion criteria: History of previous head and neck radiotherapy Generalized skin diseases Connective tissue diseases Untreated surgical wounds Currently taking proton pump inhibitors History of allergy to Esomeprazole or other topical formulation excipients

Design outcomes

Primary

Measure	Time frame
The primary endpoint is to determine whether the Esomeprazole cream can reduce the incidence of acute radiation dermatitis in comparison to placebo. Timepoint: Patients will be evaluated for acute radiation dermatitis severity weekly after every fifth RT session. Method of measurement: The severity of acute radiation dermatitis will be scored using the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria based on the clinical presentation.	—

Measure

Time frame

The primary endpoint is to determine whether the Esomeprazole cream can reduce the incidence of acute radiation dermatitis in comparison to placebo. Timepoint: Patients will be evaluated for acute radiation dermatitis severity weekly after every fifth RT session. Method of measurement: The severity of acute radiation dermatitis will be scored using the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria based on the clinical presentation.

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Secondary

Measure	Time frame
The secondary outcomes are to assess if Esomeprazole cream reduces radiotherapy-induced symptoms such as pain and moist desquamation and improves the skin-related quality of life as compared to placebo. Timepoint: Patients will be evaluated for radiotherapy-induced symptoms such as pain and moist desquamation weekly after every fifth RT session. The patients will be requested to fill out the Dermatology Life Quality Index (DLQI) form considering their feelings during the past week. Method of measurement: The size and severity of moist desquamation will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) criteria based on the clinical presentation. The worst experienced pain will be evaluated using a visual analog scale. The skin-related quality of life of the patients was appraised using the Dermatology Life Quality Index(DLQI) score.	—

Measure

Time frame

The secondary outcomes are to assess if Esomeprazole cream reduces radiotherapy-induced symptoms such as pain and moist desquamation and improves the skin-related quality of life as compared to placebo. Timepoint: Patients will be evaluated for radiotherapy-induced symptoms such as pain and moist desquamation weekly after every fifth RT session. The patients will be requested to fill out the Dermatology Life Quality Index (DLQI) form considering their feelings during the past week. Method of measurement: The size and severity of moist desquamation will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) criteria based on the clinical presentation. The worst experienced pain will be evaluated using a visual analog scale. The skin-related quality of life of the patients was appraised using the Dermatology Life Quality Index(DLQI) score.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Maham

Zanjan University of Medical Sciences

m.maham@zums.ac.ir+98 24 3347 3635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026