Comparison of black mulberry and honey syrup with benzydamine mouthwash in preventing mouth sores caused by radiotherapy in patients with head and neck cance

A comparative study of the effect of black mulberry and honey syrup with benzydamine hydrochloride mouthwash on the prevention of oral mucositis caused by radiation therapy in patients with head and neck cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250928067392N1

Enrollment

Registered

2025-10-10

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Radiotherapy-induced oral mucositis.

Interventions

Intervention 1: Intervention group: Patients with head and neck cancer who are candidates for radiotherapy and meet the inclusion criteria will receive the mulberry and honey preparation. The standard

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: above 18years old Patients with head and neck cancer candidates for radiotherapy Life expectancy of more than one year as estimated by the physician or medical team Physical and mental ability to cooperate in completing the questionnaire with a Karnofsky performance status > 50 Willingness to participate in the study Presence of at least two subsites of the oral mucosa within the radiotherapy field No known allergy to black mulberry or honey

Exclusion criteria

Exclusion criteria: Previous radiotherapy and history of chemotherapy within the last six months in the oral cavity and oropharynx region Presence of active oral infection or ulcer before initiation of radiotherapy Pregnancy

Design outcomes

Primary

Measure	Time frame
Oral Mucositis Severity. Timepoint: Assessment of oral mucositis severity every week from the start of intervention until two weeks after its completion. Method of measurement: Examination by a radio-oncology specialist based on the World Health Organization (WHO) oral mucositis scale.	—

Secondary

Measure	Time frame
Oral pain. Timepoint: Daily until two weeks after the completion of the intervention. Method of measurement: Visual Analogue Scale.;Quality of Life. Timepoint: Basis of intervention, third week of intervention, end of intervention, and two weeks after completion of intervention. Method of measurement: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Head & Neck 35.	—

Measure

Time frame

Oral pain. Timepoint: Daily until two weeks after the completion of the intervention. Method of measurement: Visual Analogue Scale.;Quality of Life. Timepoint: Basis of intervention, third week of intervention, end of intervention, and two weeks after completion of intervention. Method of measurement: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Head & Neck 35.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyde Sedighe Yousefi

Mazandaran University of Medical Sciences

dr_ssyosefi@yahoo.com009833243117

Outcome results

None listed

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