The Effect of Manuka Honey on Oral Mucositis

Phase 2

• Conditions: Oral Mucositis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12609000012279
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients with head and neck malignancies whose radiation therapy treatment (based on treatment plans) delivers a minimum of 4000cGy to at least 2 anatomical locations in the oral cavity.

Exclusion Criteria

1.Previous radiation therapy,
2.Presence of systemic disease,
3.Diabetes,
4.Allergy to honey.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total mucositis scores. Mucositis scores will be done using a validated scoring system (Epstein et al., 2001). Basically the oral cavity will be divided into 14 anatomical sites and each site is scored 0-4 (O: no change, 1: erythema<50% of area, 2: erythema >50% of area, 3: single ulcer<1cm, 4: multiple ulcers or single ulcer>1cm). Scoring will be done by a radiation therapist who will have received appropriate training for this.[Mucositis scores will be done 3 times a week during the entire radiation therapy (RT) treatment. After completion of treatment 2 more assessments will be done: at 2 and 4 weeks after completion of radiation therapy (RT) treatment]