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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (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:

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Mahin Bakhshi, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01195233     History of Changes
Other Study ID Numbers: QUMS 1350
Study First Received: August 27, 2010
Last Updated: April 18, 2011
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013