The Effectiveness of a Thyme and Honey Spray for Oral Toxicities (HONEY)

Cyprus University of Technology

Status: Enrolling

Conditions: Cancer of the Head and Neck; Xerostomia; Radiation Toxicity; Oral Mucositis

Treatments: Dietary Supplement: Placebo oral spray; Dietary Supplement: Thyme and Honey-based oral spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04880148

21-HONEY-CUT

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Thyme and Honey-based oral spray

Experimental group

Description:

Thyme and Honey-based oral spray

Treatment:

Dietary Supplement: Thyme and Honey-based oral spray

Placebo oral spray

Placebo Comparator group

Description:

Placebo oral spray

Treatment:

Dietary Supplement: Placebo oral spray