Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients

Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment

Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).

Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer Patients
• Intervention / Treatment: Drug: thyme honey mouth rinse; Drug: saline mouth rinse

Detailed Description

28 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).

Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry- Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients referred to non-palliative head and neck radiotherapy
• Total dose of radiation received (50-70 Gy)
• Patients with complaint of xerostomia
• Age 25-65 years old
• Objective dry mouth score from ( 2-5)
• Subjective dry mouth score from (1-4)
• Undergoing radiotherapy for at least three weeks
• Can independently complete the questionnaire

Exclusion Criteria:

• Have confirmed systemic diseases or medications associated with xerostomia
• Have a known allergy to honey
• Patients who had salivary glands removal surgery
• Patients with salivary gland diseases or malignancy
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: thyme honey; oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017)	Drug: thyme honey mouth rinse; oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017)
Active Comparator: Saline; oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy.	Drug: saline mouth rinse; saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective dry mouth score	Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints.	change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective dry mouth score	Objective dry mouth score: The patients will be examined for their signs of dry mouth including: (Osailan et al., 2011).; pooled saliva loss; stickiness of mouth mirror to buccal mucosa; stringy or foamy appearance of saliva; dehydration of the lips; no response to parotid stimulation Calculation of Objective dry mouth scores will be according to the number of dry mouth signs observed (0-5) and patients with less than 2 score will be excluded	change from baseline at 4 weeks
salivary PH	identification of PH according to the color of the PH paper	change from baseline at 4 weeks
nitric oxide levels	assessment of nitric oxide levels in the salivary samples using ELISA	change from baseline at 4 weeks
Salivary flow rate	assessing unstimulated salivary flow rate in 5 minutes	change from baseline at 4 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Susan Seif, professor, Faculty of Dentistry- Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: nitric oxide; xerostomia; thyme honey
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: FDASU-REC 111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No