Comparative Analysis of BioXtra on Xerostomia

NCT ID: NCT01195233

Last Updated: 2011-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-09-30

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 .

Conditions

Radiation-Induced Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

bioxtra

Intervention Type: DRUG

spray /mouth rinse

Interventions

bioxtra

spray /mouth rinse

Intervention Type: DRUG

Other Intervention Names

saliva subsitute

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Khomeini Hospital

OTHER

Sponsor Role: collaborator

Qazvin University Of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Qazvin University Of Medical Sciences

Principal Investigators

Mahin Bakhshi, DDS/MS

Role: STUDY_CHAIR

Qazvin University Of Medical Sciences

Touba Karagah, DDS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Soheila Manifar, DDS/MS

Role: STUDY_DIRECTOR

Imam Khomeini Hospital

Navid Mohamadi, PHD

Role: STUDY_DIRECTOR

QUMS

Abbas Hosseinmardi, DDS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Locations

Qazvin University of Medical Sciences

Qazvin, Qazvin Province, Iran

Countries

Iran

Other Identifiers

QUMS 1350

Identifier Type: -

Identifier Source: org_study_id