A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Change from baseline in Xerostomia grades
Study Overview
Brief Summary
The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)
Detailed Description
Radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. Exposure of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation epithelitis towards the second and third weeks of conventional fractionated radiotherapy. Likewise, salivary flow may decrease by approximately 50% during the first week of radiotherapy and upwards of 80% by the seventh week of treatment. Acute radiation-induced xerostomia is associated with inflammatory reaction. The study will include an intervention and a control group, one receiving honey prior and after the radiotherapy and the other group not receiving honey at all.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who receive radiotherapy (RT) to the oral cavity will be included in the study.
- •Patients with a confirmed histologic diagnosis of head and neck cancer referred to non-palliative radiotherapy will enter into this trial.
- •aged over 18
- •receiving radiotherapy for at least four weeks
Exclusion Criteria
- •Allergic to honey
- •confirmed and medically treated diabetes mellitus
Outcomes
Primary Outcomes
Change from baseline in Xerostomia grades
Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in oral mucositis grades
Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary Outcomes
- Change in baseline weight in one month(4 weeks)
- Changes in the General satisfaction of comfort(1 week, 2 week, 3 week, 4 week)
Investigators
Dr. Andreas Charalambous
Lecturer-Researcher
Cyprus University of Technology