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

Primary Purpose

Radiation-induced Mucositis of Oral Mucous Membranes

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
propolis
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation-induced Mucositis of Oral Mucous Membranes focused on measuring propolis, mucositis, radiotherapy, cancer

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mashhad University of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo mouth wash

propolis

Arm 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

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

Outcomes

Primary Outcome Measures

NCI.CTC Scale
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 Outcome Measures

hyposalivation scale
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

Full Information

First Posted
June 1, 2011
Last Updated
November 21, 2012
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01375088
Brief Title
Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
Official Title
Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-induced Mucositis of Oral Mucous Membranes
Keywords
propolis, mucositis, radiotherapy, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo mouth wash
Arm Type
Placebo Comparator
Arm 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
Arm Title
propolis
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
propolis
Intervention Description
15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow
Primary Outcome Measure Information:
Title
NCI.CTC Scale
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.
Time Frame
9 month
Secondary Outcome Measure Information:
Title
hyposalivation scale
Description
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
Time Frame
9 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arghavan tonkaboni, resident
Organizational Affiliation
oral medicine dep, dental school, mashhad university of medical science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University of Medical Science
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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