Effectiveness of timolol mouthwash to prevention chemotherapy-induced mucositis

Randomized clinical trial of the effectiveness of timolol mouthwash to prevention chemotherapy-induced mucositis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190810044500N9

Enrollment

Registered

2021-01-09

Start date

2020-10-09

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Chemotherapy-induced mucositis. Encounter for antineoplastic chemotherapy

Interventions

Intervention 1: Intervention group: patients will take timolol 0.5% in combination with hyaluronic acid 0.25% and xylitol 0.75% mouthwash three times a day for six weeks. Intervention 2: Control group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients over 18 years of age undergo chemotherapy Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects

Exclusion criteria

Exclusion criteria: Intolerance to medication, misuse of mouthwash People with a history of bradycardia

Design outcomes

Primary

Measure	Time frame
Clinical presentation. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination.;The severity of mucositis. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination and checklists for WHO in 5 grades.;The severity of the pain. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination based on the VAS index.	—

Measure

Time frame

Clinical presentation. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination.;The severity of mucositis. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination and checklists for WHO in 5 grades.;The severity of the pain. Timepoint: Before starting chemotherapy, after starting chemotherapy every week and finally one week after the end of mouthwash consumption (8 visits in total). Method of measurement: Oral examination based on the VAS index.

—

Secondary

Measure	Time frame
Quality of life. Timepoint: End of the study. Method of measurement: According to the questionnaire EORTC QLQ-C30 (version 3).;Complications observed. Timepoint: End of the study. Method of measurement: Based on the doctor's observation and the person's statements.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 35 3820 3419

Outcome results

None listed

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