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

Phase 2
18 Years
Not Enrolling
Radiation-Induced Xerostomia

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Trial Information

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

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 .

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

Type of Study:


Study Design:

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

Outcome Measure:

improvement of xerostomia

Outcome Description:

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

Outcome Time Frame:

2 weeks

Safety Issue:


Principal Investigator

Mahin Bakhshi, DDS/MS

Investigator Role:

Study Chair

Investigator Affiliation:

Qazvin University Of Medical Sciences


Iran: Ethics Committee

Study ID:

QUMS 1350



Start Date:

July 2010

Completion Date:

September 2010

Related Keywords:

  • Radiation-Induced Xerostomia
  • Xerostomia
  • Radiotherapy of head and neck
  • BioXtra
  • Xerostomia