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A study on the effectiveness of gargling to prevent oral mucositis caused by chemotherapy or radiochemotherapy

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Head and neck cancer, breast cancer, and gynecological cancer scheduled for initial chemotherapy or
Date of first enrollment	30/04/2026
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	Following the instructions in the package insert, prepare a gargle solution by dissolving 5 drops of Azunol 4% gargle solution in 100 ml of tap water. In both groups, the following interventions will be performed 7 times a day (after waking, after breakfast, before and after lunch, before and after dinner, and before bedtime) for 12 weeks. Each of the following interventions will be performed individually. Swallowing group*: Use 100 ml of gargle solution per gargle. Facing forward and with the mouth closed, gargle for 5 seconds, focusing on ensuring the solution reaches the entire oral mucosa. Gurgling group: Use 100 ml of gargle solution per gargle. Facing directly upwards and with the mouth open, gargle for 5 seconds, focusing on ensuring the solution reaches the entire pharyngeal mucosa. *For pharyngeal and laryngeal cancer patients assigned to the gargling group, they should first perform a gargling motion (5 seconds/time) followed by a bubbling gargle (5 seconds/time).

Outcome(s)

Primary Outcome	CTCAE Ver.3.0 Oral mucositis incidence rate of Grade 2 or higher
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Patients who are 18 years of age or older at the time of consent 2)Patients with head and neck cancer, breast cancer, or gynecological cancer who are scheduled for initial chemotherapy or chemotherapy with radiation
Exclude criteria	1)Patients using oral steroid ointment 2)Patients with impaired swallowing function who are at risk of aspiration 3)Other patients who are deemed ineligible by the principal investigator and co-investigators