The Effect of Honey on Xerostomia and Oral Mucositis (AC-H)
This study is currently recruiting participants.
Verified January 2013 by Cyprus University of Technology
Sponsor:
Cyprus University of Technology
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01465308
First received: October 31, 2011
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Dietary Supplement: Honey mouthwash Other: Normal Saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cyprus University of Technology:
Primary Outcome Measures:
- Change from baseline in Xerostomia grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
- Change from baseline in oral mucositis grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in the General satisfaction of comfort [ Time Frame: 1 week, 2 week, 3 week, 4 week ] [ Designated as safety issue: No ]
- Change in baseline weight in one month [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: receiving Honey
The patients will receive honey mouthwash rinses
|
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
|
|
Active Comparator: Saline mouthwash
The patients in this group will receive saline rinses
|
Other: Normal Saline
Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465308
Contacts
| Contact: Melanie Charalambous, PhDc | 0035799514855 | melanie.charalambous@cut.ac.cy |
Locations
| Cyprus | |
| Bank of Cyprus Oncology Centre | Recruiting |
| Nicosia, Cyprus, 2006 | |
| Contact: Melanie Charalambous, PhD c 0035799514855 melanie.charalambous@cut.ac.cy | |
| Principal Investigator: Andreas Charalambous, PhD | |
Sponsors and Collaborators
Cyprus University of Technology
Investigators
| Principal Investigator: | Andreas Charalambous, PhD | Cyprus University of Technology |
More Information
No publications provided
| Responsible Party: | Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology |
| ClinicalTrials.gov Identifier: | NCT01465308 History of Changes |
| Other Study ID Numbers: | AC-HANHS-86 |
| Study First Received: | October 31, 2011 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Cyprus: Ministry of Health |
Keywords provided by Cyprus University of Technology:
|
head and neck cancer radiotherapy induced xerostomia radiotherapy induced oral mucositis RCT symptom management |
Additional relevant MeSH terms:
|
Salivary Gland Diseases Head and Neck Neoplasms Stomatitis Xerostomia Mucositis Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013