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

Primary Purpose

Head and Neck Cancer Patients

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
thyme honey mouth rinse
saline mouth rinse
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer Patients focused on measuring xerostomia, thyme honey, nitric oxide

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • faculty of dentistry- Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

thyme honey

Saline

Arm Description

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)

oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
salivary PH
identification of PH according to the color of the PH paper
nitric oxide levels
assessment of nitric oxide levels in the salivary samples using ELISA
Salivary flow rate
assessing unstimulated salivary flow rate in 5 minutes

Full Information

First Posted
April 5, 2023
Last Updated
May 5, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05859711
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer Patients
Keywords
xerostomia, thyme honey, nitric oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thyme honey
Arm Type
Experimental
Arm Description
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)
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
thyme honey mouth rinse
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
saline mouth rinse
Intervention Description
saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy
Primary Outcome Measure Information:
Title
subjective dry mouth score
Description
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.
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
objective dry mouth score
Description
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
Time Frame
change from baseline at 4 weeks
Title
salivary PH
Description
identification of PH according to the color of the PH paper
Time Frame
change from baseline at 4 weeks
Title
nitric oxide levels
Description
assessment of nitric oxide levels in the salivary samples using ELISA
Time Frame
change from baseline at 4 weeks
Title
Salivary flow rate
Description
assessing unstimulated salivary flow rate in 5 minutes
Time Frame
change from baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Seif, professor
Organizational Affiliation
faculty of dentistry- Ain Shams university
Official's Role
Study Director
Facility Information:
Facility Name
faculty of dentistry- Ain shams university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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