Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedNovember 22, 2012
November 1, 2012
5 months
June 1, 2011
November 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
9 month
Secondary Outcomes (1)
hyposalivation scale
9 month
Study Arms (2)
placebo mouth wash
PLACEBO COMPARATOR10 patients swish \& swallow 15 ml placebo mouth wash for at least 5 min from the first session of radiotherapy until the last session
propolis
ACTIVE COMPARATOR10 patients swish \& swallow 15 ml propolis mouth wash for at least 5 min from the first session of radiotherapy until the last session
Interventions
15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow
Eligibility Criteria
You may qualify if:
- need of radiotherapy
- at least half of the mouth in the field of radiation
- dose 50 -70 Gy
- head \& neck malignancy
You may not qualify if:
- systemic disease
- FBS \> 150 WBC \> 3000
- history of radiotherapy
- need of chemotherapy
- systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mashhad University of Medical Science
Mashhad, Khorasan Razavi, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
arghavan tonkaboni, resident
oral medicine dep, dental school, mashhad university of medical science
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 17, 2011
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
November 22, 2012
Record last verified: 2012-11