Clinical trial NCT01465308: The Effect of Honey on Xerostomia and Oral Mucositis
Official title: A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
radiotherapy induced xerostomia
radiotherapy induced oral mucositis
RCT
symptom management
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2011-11-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Xerostomia grades
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
measure: Change from baseline in oral mucositis grades
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes:
measure: Changes in the General satisfaction of comfort
timeFrame: 1 week, 2 week, 3 week, 4 week
measure: Change in baseline weight in one month
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Centre
Study officials:
affiliation: Cyprus University of Technology
name: Andreas Charalambous, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.