Comparative Analysis of BioXtra on Xerostomia

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01195233

Acronym

BioXtra

Enrollment

Registered

2010-09-06

Start date

2010-07-31

Completion date

2010-09-30

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation-Induced Xerostomia

Keywords

Xerostomia, Radiotherapy of head and neck, BioXtra

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 .

Interventions

DRUGbioxtra

spray /mouth rinse

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026