Radiation-induced Mucositis of Oral Mucous Membranes
Conditions
Keywords
propolis, mucositis, radiotherapy, cancer
Brief summary
The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.
Detailed description
Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.
Interventions
DRUGpropolis
15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- age \>15 * need of radiotherapy * at least half of the mouth in the field of radiation * dose 50 -70 Gy * head & neck malignancy
Exclusion criteria
* systemic disease * FBS \> 150 WBC \> 3000 * history of radiotherapy * need of chemotherapy * systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NCI.CTC Scale | 9 month | we use NCI-CTC scale for patients in 2 groups to assess effect of propolis mouth wash on prevention and treatment of mucositis in patients under radiotherapy.We measured signs(size and sypmtoms) of mucositis by NCI-CTC scale and also we assessed the onset of the mucositis to describe the prevention efficacy of propolis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hyposalivation scale | 9 month | we use a scale for patients in 2 groups to assess effect of propolis maouth wash on subjective xerostomy and signs of candidiasis in patiants under radiotherapy |
Countries
Iran
Outcome results
None listed