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NCT Number: NCT05859711

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

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.

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Key information

Conditions

Head and Neck Cancer Patients Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of dentistry- Ain shams university

Cairo, Egypt

About this study

90 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thyme honey mouth rinse

Drug

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

Drug

saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy

Primary outcomes

  1. subjective dry mouth score

    Time frame: change from baseline at 4 weeks

    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 outcomes

  1. objective dry mouth score

    Time frame: change from baseline at 4 weeks

    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

  2. salivary PH

    Time frame: change from baseline at 4 weeks

    identification of PH according to the color of the PH paper

  3. nitric oxide levels

    Time frame: change from baseline at 4 weeks

    assessment of nitric oxide levels in the salivary samples using ELISA

  4. Salivary flow rate

    Time frame: change from baseline at 4 weeks

    assessing unstimulated salivary flow rate in 5 minutes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 16, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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