Clinical trial NCT05648682: Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis
Official title: Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis Management in Head and Neck Cancer Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancers
Oral Mucositis
Keywords: nurse
radiotherapy
salin
sodium bicarbonate
thyme honey
Head and Neck Cancers
Oral Mucositis
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of control group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of saline group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of sodium bicarbonate group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of thyme honey group patients with oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of control group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of saline group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of sodium bicarbonate group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Week 0
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: First week of radiotherapy
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Second week of radiotherapy
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Third week of radiotherapy
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fourth week of radiotherapy
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Fifth week of radiotherapy
measure: Number of thyme honey group patients with severe oral mucositis assessed by National Cancer Institute Criteria For Adverse Events v4.03 (NCI-CTCAE v4.03)
timeFrame: Sixth week of radiotherapy
measure: Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Week 0
measure: Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Second week of radiotherapy
measure: Control group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Fifth week of radiotherapy
measure: Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Week 0
measure: Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Second week of radiotherapy
measure: Saline group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Fifth week of radiotherapy
measure: Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Week 0
measure: Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Second week of radiotherapy
measure: Sodium bicarbonate group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Fifth week of radiotherapy
measure: Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Week 0
measure: Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Second week of radiotherapy
measure: Thyme honey group patients' quality-of-life scores as assessed by The University of Washington Quality of Life Questionnaire
timeFrame: Fifth week of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Zeynep YILMAZ
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Fatma İlknur ÇINAR
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Zeynep YILMAZ
role: STUDY_CHAIR
References: