Comparative Analysis of BioXtra on Xerostomia

Phase 2

Completed

• Conditions: Radiation-Induced Xerostomia
• Interventions: Drug: bioxtra

• Registration Number: NCT01195233
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief Summary

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

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 .

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Primary Completion: 2010-08
• Study First Submitted: 2010-08-27
• Study Completion: 2010-09
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
bioxtra spray and mouth rinse	bioxtra	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.

Primary Outcome Measures

Name	Time	Method
improvement of xerostomia	2 weeks	change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire\[ Time Frame: baseline compared with measures on day 14

Secondary Outcome Measures

Name	Time	Method
comparative analysis of improvement xerostomia between 2 drugs	5 weeks	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

Trial Locations

Locations (1)

Qazvin University of Medical Sciences; 🇮🇷 Qazvin, Iran, Islamic Republic of