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

Study Overview
=================
Brief Summary
-----------------
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.

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).

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

Conditions
-----------------
Head and Neck Cancer Patients

Intervention / Treatment
-----------------
* Drug: thyme honey mouth rinse
* Drug: saline mouth rinse


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thyme honey<br>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<br>* 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)<br>|
| Active Comparator: Saline<br>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<br>* saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
xerostomia, thyme honey, nitric oxide