Efficacy of a zinc mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190123042475N1

Enrollment

Registered

2019-06-09

Start date

2019-04-21

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

oral mucositis. Oral mucositis (ulcerative)

Interventions

Intervention 1: Intervention group: 1% zinc sulfate, surfactant, and various suppositories (methyl cellulose, hydroxypropylmethyl cellulose, xanthan gum) will be used to prepare the mouthwash. The fir

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All the cancer patients over 18 treated by radiotherapy

Exclusion criteria

Exclusion criteria: Incidence of co-existing systematic diseases

Design outcomes

Primary

Measure	Time frame
Creating mucositis based on clinical manifestations (Clinical presentation), severity of mucositis based on the WHO benchmark. Timepoint: In the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: To test mucositis, the WHO classification system is divided into five degrees Grade 0 : None Grade 1 :Soreness + / - Erythema Grade 2 : Erythema , ulcer , patients can swallow solid diet Grade 3 : Ulcer , Extensive erythema , patients can not swallow solid diet Grade 4 : Mucositis to the extent that alimentation is not possible.	—

Measure

Time frame

Creating mucositis based on clinical manifestations (Clinical presentation), severity of mucositis based on the WHO benchmark. Timepoint: In the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: To test mucositis, the WHO classification system is divided into five degrees Grade 0 : None Grade 1 :Soreness + / - Erythema Grade 2 : Erythema , ulcer , patients can swallow solid diet Grade 3 : Ulcer , Extensive erythema , patients can not swallow solid diet Grade 4 : Mucositis to the extent that alimentation is not possible.

—

Secondary

Measure	Time frame
Patients' quality of life and complications. Timepoint: at the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: Quality of life will also be measured using a questionnaire used in previous studies, which measures 0 to 4:Grade 0 (Complications have no effect on daily activities), Grade 1 (Symptoms cause discomfort at least once a week)Grade 2 (symptoms interact with your daily activities more than once a week), Grade 3 (symptoms also interfere with basic activities of life)Grade 4 (symptoms are such that the patient is afraid to leave the home, leading a sharp reduction in the individual's social activities.	—

Measure

Time frame

Patients' quality of life and complications. Timepoint: at the beginning of the study (before the onset of intervention), 1,2,3,4,5,6,7,8 weeks after commencing oral intake of zinc sulfate. Method of measurement: Quality of life will also be measured using a questionnaire used in previous studies, which measures 0 to 4:Grade 0 (Complications have no effect on daily activities), Grade 1 (Symptoms cause discomfort at least once a week)Grade 2 (symptoms interact with your daily activities more than once a week), Grade 3 (symptoms also interfere with basic activities of life)Grade 4 (symptoms are such that the patient is afraid to leave the home, leading a sharp reduction in the individual's social activities.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh sahebnasagh

Bojnourd University of Medical Sciences

Marzieh.saheb@gmail.com+98 98583272856

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026