Cancer of the Head and NeckHONEYNCT04880148
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
A study testing Thyme and Honey-based oral spray in people with Cancer of the Head and Neck and Xerostomia, run by Cyprus University of Technology at 2 sites in Cyprus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck, Xerostomia, Oral Mucositis
- What is being tested?
- Thyme and Honey-based oral spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesCyprus
- Study dates
- 3 Nov 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Cyprus2 sites, 2 recruiting
- Recruiting
German Oncology Center
Limassol, 4108
Konstantinos Ferentinos, MD, PhD, 25208000, Konstantinos.Ferentinos@goc.com.cy
Constantina Cloconi, MSc, RN, 25208000, Constantina.Cloconi@goc.com.cy
- Not yet recruiting
Bank of Cyprus Oncology Center
Nicosia, 2006
Dimitrios Vomvas, PhD, 22847408, Dimitrios.Vomvas@bococ.org.cy
Morfo Georgiou, MD, 22847601, Morfo.Georgiou@bococ.org.cy
About this study
Official title: The Effectiveness of a Thyme and Honey Spray for the Management of Oral Mucositis and Xerostomia in Head and Neck Cancer Patients Undergoing Radiotherapy
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.
Read more
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.
- Being tested
- Thyme and Honey-based oral spray, Placebo oral spray
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia, Stomatitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyme and Honey-based oral sprayDietary supplement
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
Placebo oral sprayDietary supplement
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
| Study group | Role | What they receive |
|---|---|---|
| Thyme and Honey-based oral spray | Experimental | Thyme and Honey-based oral spray Receives: Dietary Supplement: Thyme and Honey-based oral spray |
| Placebo oral spray | Placebo comparator | Placebo oral spray Receives: Dietary Supplement: Placebo oral spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Mucositis Grade (RTOG) at weekly assessments
The scale includes 5 grades (from 0 to IV). Higher grade denotes more severe mucositis
Measured: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments
he scale includes 5 grades (from 0 to IV). Higher grade denotes more severe xerostomia
Measured: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
Secondary outcomes (4)
Change from baseline in Xerostomia Questionnaire (Dirix et al)
consists of three parts. In the first part, patients rate on a 4-likert scale (0, 1, 2, 3) the intensity of xerostomia, oral pain, taste, and dysphagia they experience and whether they suffered from more intense tooth decay or other related problems. Secondly, patients evaluate the impact of xerostomia on their Quality of Life. The Quality of Life (QoL) scales contains 15 items (ranging from 1 to 5) with a higher score indicating a worst QoL level (minimum score is 15 and the maximum is 75). Finally, patients rate the degree to which they suffered from xerostomia on a 100-mm Visual Analogue Scale (VAS).
Measured: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in Oral Mucositis Questionnaire (OMWQ)
The 12-item questionnaire is designed to evaluate the overall wellbeing of the patient relating to OM during the last week. Possible answers are scored on Likert scales containing 5, 7 and 11 points. The first 2 questions assess global health and quality of life (QOL). The questions are rated on a 7-point scale, with 1 indicating very poor and 7 indicating excellent. The fourth question, which is made up of 6 items, addresses the impact of MTS on patient function and includes a 5-point scale, with 0 indicating not limited and 4 indicating unable to do. The remaining 3 questions assess the degree of mouth and throat pain and soreness using an 11-point scale, with 0 indicating no pain or soreness and 10 indicating the worst pain or soreness imaginable or possible.
Measured: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in health-related QoL (EORTC QLQ-C30) questionnaire
The EORTC QLQ-C30 is a cancer-specific self-report questionnaire and comprises a global QOL scale (two items), five functional scales, three symptom scales and six single items. Scores QLQ-C30 are linearly transformed to a scale of 0-100, with a higher score indicating a better level of functioning or global QOL, or a worse level of symptoms or problems
Measured: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in health-related QoL (EORTC QLQ-H&N43) questionnaire
The EORTC QLQ-H\&N35 module covers specific head and neck issues, comprises ten single items and seven subscales: swallowing, senses, speech, social eating, social contact and sexuality. QLQ-H\&N35 are linearly transformed to a scale of 0-100, with a higher score indicating a better level of functioning or global QOL, or a worse level of symptoms or problem.
Measured: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start3 Nov 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- German Oncology Center, Cyprus, Bank of Cyprus Oncology Center BOCOC
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas Charalambous, PhD, Principal investigator, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880148
- Sponsor's protocol ID
- 21-HONEY-CUT
- Acronym
- HONEY
- Status last verified
- Nov 2021
- First submitted
- 5 May 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thrasyvoulou 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.
PubMed 33741726Charalambous 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.
PubMed 24877858Charalambous 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.
PubMed 29784145Charalambous 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.
PubMed 28279391
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Thyme and Honey Spray for the Management of Oral Mucositis and Xerostomia in Head and Neck Cancer Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT04880148
- Acronym / sponsor ID
- HONEY / 21-HONEY-CUT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- German Oncology Center, Cyprus, Bank of Cyprus Oncology Center BOCOC
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyme and Honey-based oral spray | Experimental | Dietary Supplement: Thyme and Honey-based oral sprayThyme and Honey-based oral spray |
| Placebo oral spray | Placebo comparator | Dietary Supplement: Placebo oral sprayPlacebo oral spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyme and Honey-based oral spray4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session | Dietary supplement | Thyme and Honey-based oral spray |
| Placebo oral spray4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session | Dietary supplement | Placebo oral spray |
Primary outcome
Change from baseline in Mucositis Grade (RTOG) at weekly assessments
Time frame: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
The scale includes 5 grades (from 0 to IV). Higher grade denotes more severe mucositis
Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments
Time frame: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
he scale includes 5 grades (from 0 to IV). Higher grade denotes more severe xerostomia
4 secondary outcomes
Change from baseline in Xerostomia Questionnaire (Dirix et al)
Time frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in Oral Mucositis Questionnaire (OMWQ)
Time frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in health-related QoL (EORTC QLQ-C30) questionnaire
Time frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Change from baseline in health-related QoL (EORTC QLQ-H&N43) questionnaire
Time frame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 33741726Thrasyvoulou 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.
- Background: PubMed 24877858Charalambous 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.
- Results publication: PubMed 29784145Charalambous 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.
- Results publication: PubMed 28279391Charalambous 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Charalambous, PhD principal investigator
Cyprus University of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyme and Honey-based oral spray in people with Cancer of the Head and Neck and Xerostomia, run by Cyprus University of Technology at 2 sites in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Charalambous, PhD (25002011, andreas.charalambous@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Mucositis Grade (RTOG) at weekly assessments (time frame: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880148, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.