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Completed

NCT Number: NCT01375088

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

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

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Key information

Conditions

Radiation-induced Mucositis of Oral Mucous Membranes Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Neoplasms Stomatognathic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mashhad University of Medical Science

Mashhad, Razavi Khorasan Province, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propolis

Drug

15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow

Primary outcomes

  1. NCI.CTC Scale

    Time frame: 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 outcomes

  1. hyposalivation scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2011
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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