Comparative Analysis of BioXtra on Xerostomia
The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia|
- improvement of xerostomia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire[ Time Frame: baseline compared with measures on day 14
- comparative analysis of improvement xerostomia between 2 drugs [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire[ Time Frame: baseline compared with measures on day 35 and comparative analysis between BioXtra spray and mouth rinse
|Study Start Date:||July 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
bioxtra spray and mouth rinse
Drug: BioXtra spray or mouth rinse Patients had been xerostomia due to radiation of head and neck were selected for the study. Gender, age, medical history, VAS, dichotomous questionnaire of xerostomia , and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received BioXtra spray and second group used BioXtra mouth rinse for 2 weeks and then 1 weeks wash -out period and for other 2 weeks drugs is switched . Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and 35 days after first visit.
spray /mouth rinse
Other Name: saliva subsitute
Xerostomia or dry mouth is an important complication of radiotherapy for head and neck regions producing serious discomfort for patients with a significant reduction in their quality of life. Symptomatic treatments for the disease include maintain oral hygiene and use of artificial saliva substitutes.
Due to limited studies on efficacy compounds BioXtra, present study compared the effects of spray and mouth rinse BioXtra in symptoms of xerostomia in patients under head and neck cancer radiotherapy .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195233
|Iran, Islamic Republic of|
|Qazvin University of Medical Sciences|
|Qazvin, Iran, Islamic Republic of, 3415759811|
|Study Chair:||Mahin Bakhshi, DDS/MS||Qazvin University Of Medical Sciences|
|Principal Investigator:||Touba Karagah, DDS||QUMS|
|Study Director:||Soheila Manifar, DDS/MS||Imam Khomeini Hospital|
|Study Director:||Navid Mohamadi, PHD||QUMS|
|Principal Investigator:||Abbas Hosseinmardi, DDS||QUMS|