Comparative Analysis of BioXtra on Xerostomia

NCT01195233 | Completed Phase 2 DMC

• 1 other identifier: QUMS 1350
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Xerostomia

Keywords

Xerostomia; Radiotherapy of head and neck; BioXtra

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (1)

• comparative analysis of improvement xerostomia between 2 drugs

  5 weeks

Study Arms (1)

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.

Drug: bioxtra

Interventions

bioxtra DRUG

spray /mouth rinse

Also known as: saliva subsitute

bioxtra spray and mouth rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• complaint of xerostomia after head and neck radiotherapy
• patient must have given written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead
• Imam Khomeini Hospital: collaborator

Study Sites (1)

Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3415759811, Iran

Location

MeSH Terms

Conditions

Xerostomia

Interventions

BioXtra

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mahin Bakhshi, DDS/MS

  Qazvin University Of Medical Sciences

  STUDY CHAIR

• Touba Karagah, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

• Soheila Manifar, DDS/MS

  Imam Khomeini Hospital

  STUDY DIRECTOR

• Navid Mohamadi, PHD

  QUMS

  STUDY DIRECTOR

• Abbas Hosseinmardi, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: September 6, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 19, 2011

Record last verified: 2010-07

Locations

IR (1)