Trials / Completed
CompletedNCT01465308
The Effect of Honey on Xerostomia and Oral Mucositis
A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Cyprus University of Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Honey 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 |
| OTHER | Normal Saline | Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2014-09-01
- Completion
- 2014-10-01
- First posted
- 2011-11-04
- Last updated
- 2014-10-08
Locations
1 site across 1 country: Cyprus
Source: ClinicalTrials.gov record NCT01465308. Inclusion in this directory is not an endorsement.