Comparative Analysis of BioXtra on Xerostomia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia

Conditions
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Radiation-Induced Xerostomia

Intervention / Treatment
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* Drug: bioxtra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: complaint of xerostomia after head and neck radiotherapy patient must have given written informed consent Exclusion Criteria: age under 18 years history of any treatment for cancer in the last 3 months recurrence of cancer and end stage of it diabetes mellitus sjogren syndrome or other medical causes of xerostomia drug therapy which might induce xerostomia refusal of cooperation or consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: bioxtra spray and mouth rinse<br>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<br>* spray /mouth rinse<br>* Other names: saliva subsitute;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, Radiotherapy of head and neck, BioXtra