Comparative Analysis of BioXtra on Xerostomia

Radiation-Induced Xerostomia Clinical Trial

— BioXtra  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195233
• Other study ID #: QUMS 1350
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2010
• Last updated: April 18, 2011
• Start date: July 2010
• Est. completion date: September 2010

Study information

• Verified date: July 2010
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Radiation-Induced Xerostomia
• Xerostomia

Intervention

Drug:
• bioxtra
spray /mouth rinse

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin University of Medical Sciences	Qazvin

Sponsors (2)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences	Imam Khomeini Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No