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Comparative Analysis of BioXtra on Xerostomia (BioXtra)

Primary Purpose

Radiation-Induced Xerostomia

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
bioxtra
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Radiation-Induced Xerostomia focused on measuring Xerostomia, Radiotherapy of head and neck, BioXtra

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qazvin University of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

bioxtra spray and mouth rinse

Arm Description

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.

Outcomes

Primary Outcome Measures

improvement of xerostomia
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
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

Full Information

First Posted
August 27, 2010
Last Updated
April 18, 2011
Sponsor
Qazvin University Of Medical Sciences
Collaborators
Imam Khomeini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01195233
Brief Title
Comparative Analysis of BioXtra on Xerostomia
Acronym
BioXtra
Official Title
Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Qazvin University Of Medical Sciences
Collaborators
Imam Khomeini Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-Induced Xerostomia
Keywords
Xerostomia, Radiotherapy of head and neck, BioXtra

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bioxtra spray and mouth rinse
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
bioxtra
Other Intervention Name(s)
saliva subsitute
Intervention Description
spray /mouth rinse
Primary Outcome Measure Information:
Title
improvement of xerostomia
Description
change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire[ Time Frame: baseline compared with measures on day 14
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
comparative analysis of improvement xerostomia between 2 drugs
Description
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
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahin Bakhshi, DDS/MS
Organizational Affiliation
Qazvin University Of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Touba Karagah, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soheila Manifar, DDS/MS
Organizational Affiliation
Imam Khomeini Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Navid Mohamadi, PHD
Organizational Affiliation
QUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abbas Hosseinmardi, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qazvin University of Medical Sciences
City
Qazvin
ZIP/Postal Code
3415759811
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparative Analysis of BioXtra on Xerostomia

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