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Comparative Analysis of BioXtra on Xerostomia

This study has been completed.
Sponsor:
Collaborator:
Imam Khomeini Hospital
Information provided by:
Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01195233
First received: August 27, 2010
Last updated: April 18, 2011
Last verified: July 2010

August 27, 2010
April 18, 2011
July 2010
August 2010   (final data collection date for primary outcome measure)
improvement of xerostomia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire[ Time Frame: baseline compared with measures on day 14
Same as current
Complete list of historical versions of study NCT01195233 on ClinicalTrials.gov Archive Site
comparative analysis of improvement xerostomia between 2 drugs [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Comparative Analysis of BioXtra on Xerostomia
Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced 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.

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 .

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Radiation-Induced Xerostomia
Drug: bioxtra
spray /mouth rinse
Other Name: saliva subsitute
bioxtra spray and mouth rinse
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.
Intervention: Drug: bioxtra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01195233
QUMS 1350
Yes
Dr Mahin Bakhshi, Qazvin University Of Medical Sciences
Qazvin University Of Medical Sciences
Imam Khomeini Hospital
Study Chair: Mahin Bakhshi, DDS/MS Qazvin University Of Medical Sciences
Principal Investigator: Touba Karagah, DDS QUMS
Study Director: Soheila Manifar, DDS/MS Imam Khomeini Hospital
Study Director: Navid Mohamadi, PHD QUMS
Principal Investigator: Abbas Hosseinmardi, DDS QUMS
Qazvin University Of Medical Sciences
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP