Radiation-Induced XerostomiaPhase 2BioXtraNCT01195233
Comparative Analysis of BioXtra on Xerostomia
A Phase 2 study testing bioxtra in people with Radiation-Induced Xerostomia, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-Induced Xerostomia
- What is being tested?
- bioxtra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jul 2010to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- complaint of xerostomia after head and neck radiotherapy
- patient must have given written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Qazvin University of Medical Sciences
Qazvin, Qazvin Province, 3415759811
About this study
Official title: 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.
Read the 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 .
- Conditions
- Radiation-Induced Xerostomia
- Being tested
- bioxtra
- Keywords
- Xerostomia, Radiotherapy of head and neck, BioXtra
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioxtraDrug
Also called saliva subsitute
spray /mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| bioxtra spray and mouth rinse | Other | 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. Receives: Drug: bioxtra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (1)
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
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Imam Khomeini Hospital
- Investigators
- Mahin Bakhshi, DDS/MS, Study chair, Qazvin University Of Medical SciencesTouba Karagah, DDS, Principal investigator, QUMSSoheila Manifar, DDS/MS, Study director, Imam Khomeini HospitalNavid Mohamadi, PHD, Study director, QUMSAbbas Hosseinmardi, DDS, Principal investigator, QUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195233
- Sponsor's protocol ID
- QUMS 1350
- Acronym
- BioXtra
- Status last verified
- Jul 2010
- First submitted
- 27 Aug 2010
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia
- ClinicalTrials.gov ID
- NCT01195233
- Acronym / sponsor ID
- BioXtra / QUMS 1350
- Conditions
- Radiation-Induced Xerostomia
- Keywords
- Xerostomia, Radiotherapy of head and neck, BioXtra
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Collaborators
- Imam Khomeini Hospital
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bioxtra spray and mouth rinse | Other | Drug: bioxtraDrug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- complaint of xerostomia after head and neck radiotherapy
- patient must have given written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioxtraAlso: saliva subsitutespray /mouth rinse | Drug | bioxtra spray and mouth rinse |
Primary outcome
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
1 secondary outcome
comparative analysis of improvement xerostomia between 2 drugs
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
Related trials for Radiation-Induced Xerostomia
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Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Head and Neck Cancer
Active, not recruitingPhase 3
Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
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RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
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A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahin Bakhshi, DDS/MS study chair
Qazvin University Of Medical Sciences
Touba Karagah, DDS principal investigator
QUMS
Soheila Manifar, DDS/MS study director
Imam Khomeini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bioxtra in people with Radiation-Induced Xerostomia, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of xerostomia (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.