The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
NCT ID: NCT04880148
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-11-03
2024-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Thyme and Honey-based oral spray
Thyme and Honey-based oral spray
Thyme and Honey-based oral spray
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
Placebo oral spray
Placebo oral spray
Placebo oral spray
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
Interventions
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Thyme and Honey-based oral spray
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
Placebo oral spray
4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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German Oncology Center, Cyprus
OTHER
Bank of Cyprus Oncology Center BOCOC
UNKNOWN
Cyprus University of Technology
OTHER
Responsible Party
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Dr. Andreas Charalambous
Associate Professor
Principal Investigators
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Andreas Charalambous, PhD
Role: PRINCIPAL_INVESTIGATOR
Cyprus University of Technology
Locations
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German Oncology Center
Limassol, , Cyprus
Bank of Cyprus Oncology Center
Nicosia, , Cyprus
Countries
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Central Contacts
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Facility Contacts
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Konstantinos Ferentinos, MD, PhD
Role: primary
Constantina Cloconi, MSc, RN
Role: backup
Dimitrios Vomvas, PhD
Role: primary
Morfo Georgiou, MD
Role: backup
References
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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.
Charalambous 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.
Charalambous 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.
Charalambous 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.
Other Identifiers
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21-HONEY-CUT
Identifier Type: -
Identifier Source: org_study_id