Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Radiation-induced Mucositis of Oral Mucous Membranes

Treatments: Drug: propolis

Study type: Interventional

Funder types: Other

Identifiers

NCT01375088

339888

Details and patient eligibility

About

The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.

Full description

Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.

Enrollment: 20 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

20 participants in 2 patient groups, including a placebo group

placebo mouth wash

Placebo Comparator group

Description:

10 patients swish \& swallow 15 ml placebo mouth wash for at least 5 min from the first session of radiotherapy until the last session

Treatment:

Drug: propolis

propolis

Active Comparator group

Description:

10 patients swish \& swallow 15 ml propolis mouth wash for at least 5 min from the first session of radiotherapy until the last session

Treatment:

Drug: propolis