Clinical trial NCT04880148: The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of the Head and Neck
Xerostomia
Oral Mucositis
Radiation Toxicity
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: German Oncology Center, Cyprus
name: Bank of Cyprus Oncology Center BOCOC
First posted: 2021-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
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
measure: Change from baseline in Xerostomia Grade (CTCAE) at weekly assessments
timeFrame: Baseline (week 4), week 5, week 6, week 7, week 8 and week 24
Secondary outcomes:
measure: Change from baseline in Xerostomia Questionnaire (Dirix et al)
timeFrame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
measure: Change from baseline in Oral Mucositis Questionnaire (OMWQ)
timeFrame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
measure: Change from baseline in health-related QoL (EORTC QLQ-C30) questionnaire
timeFrame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
measure: Change from baseline in health-related QoL (EORTC QLQ-H&N43) questionnaire
timeFrame: Baseline, on completion of radiotherapy, 4 weeks and 24 weeks after radiotherapy
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: German Oncology Center
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Center
Study officials:
affiliation: Cyprus University of Technology
name: Andreas Charalambous, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.