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

February 17, 2017 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visco-ease
Visco-ease is a suspension of multilamellar vesicles comprising lipids in ratios which mimic the lipidic composition of endogenous extra-alveolar lamellar bodies. Visco-ease is suspended in physiological saline (0.9% NaCl) to provide a final dose concentration of 19.6 mg/mL. Visco-ease is a white to off-white turbid suspension. The device under evaluation in this clinical investigation is Visco-ease at a concentration of 19.6 mg/mL.
19.6 mg/mL of LMS-611
Other Names:
  • RIX - LMS-611x-20
  • OXB/1-20
  • LMS-611
Placebo Comparator: RIX-Placebo
Physiological Saline (sodium chloride 0.9% (w/v)
Physiological Saline
Other Names:
  • 0.9% (w/v) Physiological Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GRIX Score
Time Frame: From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Claire Paterson, Beatson West of Scotland Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2016

Primary Completion (Actual)

February 2, 2017

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • GN14ON413
  • 00908 (Other Identifier: Funder)
  • 44528835 (Registry Identifier: ISRCTN Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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