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NCT Number: NCT01195233

Comparative Analysis of BioXtra on Xerostomia

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.

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Key information

Conditions

Radiation-Induced Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3415759811, Iran

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bioxtra

Drug

spray /mouth rinse

Other names: saliva subsitute

Primary outcomes

  1. improvement of xerostomia

    Time frame: 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 outcomes

  1. comparative analysis of improvement xerostomia between 2 drugs

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Collaborators

  • Imam Khomeini Hospital

Registry information

Official study title

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

Acronym: BioXtra

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2010
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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