The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: Afeasibility randomized control trial.

Abstract

Radiation-induced xerostomia is one of the most common side effects that head and neck cancer patients experience during and after treatment. Despite the various methods for the prevention and treatment of radiation-induced xerostomia, it remains highly prevalent among patients treated for head and neck cancers negatively influencing their lives. The purpose of this study was to evaluate the effectiveness of thyme honey as a means for managing radiation-induced xerostomia. This was a parallel randomised controlled trial with two equal arms, the experimental arm (thyme honey) and the control arm (saline). 72 head and neck cancer patients receiving radiotherapy or/and chemotherapy or/and surgery were recruited in a specialised cancer centre. Patients in both arms followed the same administration protocol with thyme honey and saline respectively. Identical assessments at baseline, 1 month and 6 months following completion of the intervention were performed in both arms including the National Cancer Institute (NCI) xerostomia scale and the Xerostomia Questionnaire (XQ) additionally to weekly oral clinical assessments. The ClinicalTrials.gov Identifier for this study is NCT01465308. Linear Mixed Models revealed the statistically significant effect of the intervention on xerostomia (F=8.474 p<0.001) and overall quality of life (F=13.158 p<0.001). Moreover, Generalised Estimating Equations revealed a statistically significant effect on strong and unbearable pain (F=10.524 p<0.001) and dysphagia (F=4.525 p=0.033). The study has demonstrated the safety and efficacy findings of Thyme honey in head and neck cancer patients for the management of treatment induced xerostomia.