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A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Change from baseline in Xerostomia grades

Outcome Time Frame:

1 week, 2 weeks, 3 weeks, 4 weeks

Safety Issue:

No

Principal Investigator

Andreas Charalambous, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cyprus University of Technology

Authority:

Cyprus: Ministry of Health

Study ID:

AC-HANHS-86

NCT ID:

NCT01465308

Start Date:

August 2011

Completion Date:

June 2013

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • radiotherapy induced xerostomia
  • radiotherapy induced oral mucositis
  • RCT
  • symptom management
  • Head and Neck Neoplasms
  • Stomatitis
  • Xerostomia
  • Mucositis

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