A Phase 2 interventional study of bioxtra in Radiation-Induced Xerostomia, sponsored by Qazvin University Of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-19.
Sponsored by Qazvin University Of Medical Sciences · Phase 2, Interventional, and Supportive care
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.
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 .
264 studies on the registry are indexed under Xerostomia; 48 are open to participants now.
This study's planned enrollment of 20 is below the median of 42 across 223 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →Qazvin University Of Medical Sciences is the lead sponsor of 34 studies on the registry; none are open to participants now.
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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.
Drug: bioxtra
spray /mouth rinse
Also known as: saliva subsitute
improvement of xerostomia
change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire\[ Time Frame: baseline compared with measures on day 14
Time frame: 2 weeks
comparative analysis of improvement xerostomia between 2 drugs
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
Time frame: 5 weeks
The record gives a start of Jul 2010, a primary completion of Aug 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Qazvin University Of Medical Sciences