Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status: Completed

Conditions: Head and Neck Cancers; Oral Mucositis

Treatments: Other: Sodium bicarbonate; Other: Thyme honey; Other: Salin; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05648682

SBU_RKC

Details and patient eligibility

About

This study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy.

Full description

The research was conducted as a randomized controlled clinical trial between January 2020 and January 2022. The sample of the research; Patients who applied to Hospital Radiotherapy Unit, received 50-60 Gy radiotherapy in the oral cavity, had a primary diagnosis of head and neck cancer, had no metastasis, had no complaints about mucositis, were older than 18 years old, spoke Turkish, and agreed to participate, in the study. With the closed-envelope randomization method, 48 patients were included in the sample, 12 patients for each of the saline, sodium bicarbonate, thyme honey, and control groups. The routine protocol of the clinic was applied to the control group. Patients in the intervention group (thyme honey, saline and sodium bicarbonate group) were treated 3 times a day for 6 weeks, in addition to the routine protocol of the clinic; they were asked to gargle with 20 ml of the solution in the group they were randomized to, 15 minutes before, 15 minutes and 6 hours after radiotherapy. Intraoral evaluations were made every week by the responsible physician of the radiotherapy unit, who did not know which group the patients were in (single blind). Study data; Obtained using the Sociodemographic and Disease Data Collection Form, the National Cancer Institute Common Toxicity Criteria v4.03, the Oral Evaluation Guide, and the Washington University Quality of Life Questionnaire. In the study, Chi-square analysis was used for the relationship between two categorical variables, One-way Anova for differences in measurements, Levene test for homogeneity of variance, and Bonferroni analysis to find out from which group or groups the difference originated. Support was received from the Health Sciences University Scientific Research Project Office for the study (2020/029)

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis is head and neck cancer
• To be receiving radiotherapy at a dose of 50-60 Gy in the oral cavity
• Not be metastatic
• OM grade 1 (according to NCI-CTCAE v4.03)
• Be 18 years or older
• Volunteer to participate in the study
• Speak Turkish

Exclusion criteria

• Have an autoimmune disease
• Have dental disease
• Using dentures
• Being allergic to thyme honey
• Refusing to participate in the research
• To have received radiotherapy treatment in the 6-month period before the start of the study

Criteria for terminating the study

• The patient's desire to leave the study
• Continuing the treatment in another city
• Interruption or termination of radiotherapy treatment
• Patient's death

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups

Saline

Experimental group

Description:

The patients in the group gargling with saline were given in a 500 ml bottle at each visit for one week of use. Patients were told that they should gargle using approximately two tablespoons of the solution given for each usage.

Treatment:

Other: Salin

Sodium Bicarbonate

Experimental group

Description:

The sodium bicarbonate solution prepared by the researcher by mixing one teaspoon of baking soda (4.5 grams) into 500 ml of distilled water by the researcher was given to the patients in the group gargling with sodium bicarbonate for a one-week use at each interview. Patients were told that they should gargle using approximately two tablespoons of the solution given for each usage.

Treatment:

Other: Sodium bicarbonate

Thyme Honey

Experimental group

Description:

20 ml of honey was diluted in 100 ml distilled water bottles by the researcher to the patients in the group gargling with thyme honey. For a week's use, the patient was given five honey solutions in 100 ml bottles at one time at each visit. Patients were told that they should gargle using approximately two tablespoons of the solution given for each use.

Treatment:

Other: Thyme honey

Control

Experimental group

Description:

No solution was given to the patients in the control group by the researcher.

Treatment:

Other: Control