Head and Neck Cancer
Conditions
Keywords
head and neck cancer, radiotherapy induced xerostomia, radiotherapy induced oral mucositis, RCT, symptom management
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.
Interventions
DIETARY_SUPPLEMENTHoney mouthwash
The patients in the intervention group will receive honey mouthwash 15 minutes before the radiotherapy session, 15 minutes after and 6 hours after the radiotherapy session
OTHERNormal Saline
Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy
Sponsors
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Xerostomia grades | 1 week, 2 weeks, 3 weeks, 4 weeks |
| Change from baseline in oral mucositis grades | 1 week, 2 weeks, 3 weeks, 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the General satisfaction of comfort | 1 week, 2 week, 3 week, 4 week |
| Change in baseline weight in one month | 4 weeks |
Countries
Cyprus
Outcome results
None listed