A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy

Xerostomia Clinical Trial

Official title:

Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687087
• Other study ID #: GN14ON413
• Secondary ID: 0090844528835
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: February 17, 2017
• Start date: March 24, 2016
• Est. completion date: February 2, 2017

Study information

• Verified date: February 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients.

A parallel group double blind study design has been selected. The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject has provided written informed consent

2. Male or female subjects = 18 years of age

3. Subjects prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of radiation as judged by the CI or PI during the radiotherapy planning process

Exclusion Criteria:

1. Subject is pregnant or breastfeeding

2. Subjects with known allergies to egg, soya, or lanolin (sheep's wool grease) based products

3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjögren's syndrome) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure

4. Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent

5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the CI or PI)

6. Subjects who are unable to independently complete the questionnaire or diary

7. Subjects who are judged inappropriate for inclusion in the study by the CI or PI

8. Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion

Related Conditions & MeSH terms

• Xerostomia

Intervention

Device:
• Visco-ease
19.6 mg/mL of LMS-611
• Placebo
Physiological Saline

Locations

Country	Name	City	State
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Lanarkshire

Sponsors (3)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Lamellar Biomedical Ltd, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in GRIX Score	The primary endpoint will compare change in GRIX scores from baseline to 6-week follow-up between the group treated with Visco-ease and the Placebo group.	From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)