Clinical trial · Interventional
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
The Effectiveness of a Thyme and Honey Spray for the Management of Oral Mucositis and Xerostomia in Head and Neck Cancer Patients Undergoing Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim: To evaluate the effectiveness of thymus honey on radiation induced-oral mucositis and xerostomia. Background: Oral mucositis and xerostomia are two of the most severe side effects that head and neck cancer patients confront during and after the completion of radiotherapy. Although several medications are used for their treatment, these fail to provide a fully effective and comprehensive management. Honey and thyme have been studied for the management of various treatment-related side effects. Design: Α double blinded randomised controlled trial will be used for this study. Methods: 200 head and neck cancer patients who receive radiotherapy will be included in this study. Patients will be randomised and divided into two equal groups of 100 participants; the intervention group (oral spray with thyme and honey + standard care) and the control group ( placebo spray + standard care). Assessments with xerostomia and oral mucositis scales additionally to 4 self-administered questionnaires will occur in both groups at baseline and then weekly and 6 months following completion of treatment. The duration of the study will be 3 years from the day of approval of this research protocol.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo oral spray | Dietary Supplement | — | UNRESOLVED |
| Thyme and Honey-based oral spray | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thyme and Honey-based oral spray
- description
- Thyme and Honey-based oral spray
- interventionNames
- Dietary Supplement: Thyme and Honey-based oral spray
- type
- PLACEBO_COMPARATOR
- label
- Placebo oral spray
- description
- Placebo oral spray
- interventionNames
- Dietary Supplement: Placebo oral spray
Primary outcomes (2)
- measure
- Change from baseline in Mucositis Grade (RTOG) at weekly assessments
- timeFrame
- Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a confirmed histologic diagnosis of head and neck cancer * Patients referred to non-palliative radiotherapy to the oral cavity will be included in the study * Synchronous or induction chemotherapy, or both, will be permitted. * Patients aged over 18, * Patients able to provide informed consent, * Patients having radiotherapy for at least three weeks (lower limit has been set at 50 Gy), * Patients able to complete records accurately Exclusion Criteria: * Patients with a confirmed and medically treated diabetes mellitus, * Patients with allergy to honey, thyme or any other ingredient, * Patients who will refuse to take part in this study and * Patients with previous radiotherapy or presence of systemic disease.
References
Publications (4)
- BACKGROUNDThrasyvoulou S, Tsitsi T, Katodritis N, Vomvas D, Charalambous M, Charalambous A. Reliability and Validity of the Greek Version of the Oral Mucositis Weekly Questionnaire in the Head and Neck Cancer Context. J Nurs Meas. 2021 Aug 1;29(2):317-333. doi: 10.1891/JNM-D-19-00096. Epub 2021 Mar 19. PMID 33741726
- BACKGROUNDCharalambous A. Hermeneutic phenomenological interpretations of patients with head and neck neoplasm experiences living with radiation-induced xerostomia: the price to pay? Eur J Oncol Nurs. 2014 Oct;18(5):512-20. doi: 10.1016/j.ejon.2014.04.007. Epub 2014 May 27. PMID 24877858
- RESULTCharalambous M, Raftopoulos V, Paikousis L, Katodritis N, Lambrinou E, Vomvas D, Georgiou M, Charalambous A. The effect of the use of thyme honey in minimizing radiation - induced oral mucositis in head and neck cancer patients: A randomized controlled trial. Eur J Oncol Nurs. 2018 Jun;34:89-97. doi: 10.1016/j.ejon.2018.04.003. Epub 2018 Apr 30. PMID 29784145
- RESULTCharalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16. PMID 28279391