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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01195233
Other study ID # QUMS 1350
Secondary ID
Status Completed
Phase Phase 2
First received August 27, 2010
Last updated April 18, 2011
Start date July 2010
Est. completion date September 2010

Study information

Verified date July 2010
Source Qazvin University Of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical 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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
bioxtra
spray /mouth rinse

Locations

Country Name City State
Iran, Islamic Republic of Qazvin University of Medical Sciences Qazvin

Sponsors (2)

Lead Sponsor Collaborator
Qazvin University Of Medical Sciences Imam Khomeini Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 5 weeks No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05060341 - Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia
Completed NCT02589938 - Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer N/A
Terminated NCT00682747 - Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy Phase 2
Completed NCT03035825 - Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients N/A
Completed NCT01885065 - Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients N/A
Completed NCT05020067 - Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy Phase 2
Recruiting NCT06413550 - The Efficacy of Hibiscus Sabdariffa in Xerostomia N/A
Recruiting NCT06414161 - Management of Radiotherapy-related Xerostomia With Green Tea and Peppermint N/A