Comparative Analysis of BioXtra on Xerostomia (BioXtra)

April 18, 2011 updated by: Qazvin University Of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • saliva subsitute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qazvin University Of Medical Sciences

Collaborators

Imam Khomeini Hospital

Investigators

  • Principal Investigator: Touba Karagah, DDS, QUMS
  • Study Chair: Mahin Bakhshi, DDS/MS, Qazvin University of Medical Sciences
  • Study Director: Soheila Manifar, DDS/MS, Imam Khomeini Hospital
  • Study Director: Navid Mohamadi, PHD, QUMS
  • Principal Investigator: Abbas Hosseinmardi, DDS, QUMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUMS 1350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Radiation-Induced Xerostomia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe