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


Phase 2
15 Years
N/A
Not Enrolling
Both
Radiation-induced Mucositis of Oral Mucous Membranes

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

NCI.CTC Scale

Outcome Description:

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.

Outcome Time Frame:

9 month

Safety Issue:

No

Principal Investigator

arghavan tonkaboni, resident

Investigator Role:

Principal Investigator

Investigator Affiliation:

oral medicine dep, dental school, mashhad university of medical science

Authority:

Iran: Ethics Committee

Study ID:

339888

NCT ID:

NCT01375088

Start Date:

October 2010

Completion Date:

May 2011

Related Keywords:

  • Radiation-induced Mucositis of Oral Mucous Membranes
  • propolis
  • mucositis
  • radiotherapy
  • cancer
  • Head and Neck Neoplasms
  • Mucositis

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