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

NCT ID: NCT05648682

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-01-01

Brief Summary

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.

Detailed 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)

Conditions

Head and Neck Cancers; Oral Mucositis

Keywords

nurse; radiotherapy; salin; sodium bicarbonate; thyme honey; Head and Neck Cancers; Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Saline

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.

Group Type: EXPERIMENTAL

Salin

Intervention Type: OTHER

Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use. SF solution was obtained from the medical company as 500 ml separately for each patient.

Sodium Bicarbonate

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.

Group Type: EXPERIMENTAL

Sodium bicarbonate

Intervention Type: OTHER

Patients were told that they should gargle using approximately two tablespoons of the solution given for each use. The 500 ml distilled water bottle to be used for the SB solution was obtained from the medical company, separately for each patient.

Thyme Honey

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.

Group Type: EXPERIMENTAL

Thyme honey

Intervention Type: OTHER

Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use.

Control

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

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

The patients continued to use the antifungal solution containing the active ingredient nystatin, which was prescribed routinely in the clinical procedure, 3 times a day.

Interventions

Salin

Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use. SF solution was obtained from the medical company as 500 ml separately for each patient.

Intervention Type: OTHER

Sodium bicarbonate

Patients were told that they should gargle using approximately two tablespoons of the solution given for each use. The 500 ml distilled water bottle to be used for the SB solution was obtained from the medical company, separately for each patient.

Intervention Type: OTHER

Thyme honey

Patients were told that they should gargle using approximately 2 tablespoons of the solution given for each use.

Intervention Type: OTHER

Control

The patients continued to use the antifungal solution containing the active ingredient nystatin, which was prescribed routinely in the clinical procedure, 3 times a day.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Yilmaz

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma İlknur ÇINAR

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Zeynep YILMAZ

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Locations

Zeynep YILMAZ

Bilecik, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBU_RKC

Identifier Type: -

Identifier Source: org_study_id