Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis

Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220213054015N1

Enrollment

Registered

2022-04-12

Start date

2022-05-20

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

chemotherapy-induced oral mucositis.

Interventions

Intervention 1: Intervention group:Patients will gargle 4 ml of melatonin mouthwash made in Alborz School of Pharmacy, three times a day (a measuring cup with defined volume will be provided to facili

patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone

patients will also be inquired to join the survey in case of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 and above. A patient with malignant solid tumor and candidate for chemotherapy (receiving medications with potential of almost similar mucositis: Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Gemcitabine, Dacarbazine, and Cisplatin). Karnofsky status = ??%. Oral and written satisfaction (consent) of patients to participate in survey.

Exclusion criteria

Exclusion criteria: Inability in using the mouthwash. Smoking. Increasing hypersensitivity to melatonin or any other components used in formulation. History of head and neck radiotherapy. Having any lesions inside the mouth.

Design outcomes

Primary

Measure	Time frame
Intensity of mucositis. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: World Health Organization Toxicity Scale.	—

Secondary

Measure	Time frame
Intensity of pain. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: Visual analog scale.;Quality of Life. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: EORTC Quality of Life Questionnaire QLQ-C30.	—

Measure

Time frame

Intensity of pain. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: Visual analog scale.;Quality of Life. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: EORTC Quality of Life Questionnaire QLQ-C30.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElliyeh Ghadrdan

Karaj University of Medical Sciences

EL.ghardan@gmail.com+98 26 3256 7175

Outcome results

None listed

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