Clinical trial NCT05859711: Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients
Official title: Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Cancer Patients
Keywords: xerostomia
thyme honey
nitric oxide
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: subjective dry mouth score
timeFrame: change from baseline at 4 weeks
Secondary outcomes:
measure: objective dry mouth score
timeFrame: change from baseline at 4 weeks
measure: salivary PH
timeFrame: change from baseline at 4 weeks
measure: nitric oxide levels
timeFrame: change from baseline at 4 weeks
measure: Salivary flow rate
timeFrame: change from baseline at 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry- Ain shams university
Study officials:
affiliation: faculty of dentistry- Ain Shams university
name: Susan Seif, professor
role: STUDY_DIRECTOR
References: