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

Head and Neck Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05859711
• Other study ID #: FDASU-REC 111
• Status: Completed
• Phase: Phase 4
• Start date: February 20, 2021
• Est. completion date: June 20, 2021

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer Patients
• Xerostomia

Intervention

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)
• 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

Locations

Country	Name	City	State
Egypt	faculty of dentistry- Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	salivary PH	identification of PH according to the color of the PH paper	change from baseline at 4 weeks
Secondary	nitric oxide levels	assessment of nitric oxide levels in the salivary samples using ELISA	change from baseline at 4 weeks
Secondary	Salivary flow rate	assessing unstimulated salivary flow rate in 5 minutes	change from baseline at 4 weeks