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Comparative Analysis of BioXtra on Xerostomia (BioXtra)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195233
First Posted: September 6, 2010
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Imam Khomeini Hospital
Information provided by:
Qazvin University Of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Radiation-Induced Xerostomia Drug: bioxtra Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: July 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: bioxtra
spray /mouth rinse
Other Name: saliva subsitute

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 .

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195233


Locations
Iran, Islamic Republic of
Qazvin University of Medical Sciences
Qazvin, Iran, Islamic Republic of, 3415759811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Imam Khomeini Hospital
Investigators
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
  More Information

Responsible Party: Dr Mahin Bakhshi, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01195233     History of Changes
Other Study ID Numbers: QUMS 1350
First Submitted: August 27, 2010
First Posted: September 6, 2010
Last Update Posted: April 19, 2011
Last Verified: July 2010

Keywords provided by Qazvin University Of Medical Sciences:
Xerostomia
Radiotherapy of head and neck
BioXtra

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases