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

Primary Purpose

Xerostomia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Visco-ease
Placebo
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Xerostomia focused on measuring Radiotherapy Induced Xerostomia (RIX)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beatson West of Scotland Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Visco-ease

RIX-Placebo

Arm Description

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.

Physiological Saline (sodium chloride 0.9% (w/v)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2016
Last Updated
February 17, 2017
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Lamellar Biomedical Ltd, University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT02687087
Brief Title
A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy
Official Title
Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 24, 2016 (Actual)
Primary Completion Date
February 2, 2017 (Actual)
Study Completion Date
February 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Lamellar Biomedical Ltd, University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
Radiotherapy Induced Xerostomia (RIX)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visco-ease
Arm Type
Experimental
Arm Description
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.
Arm Title
RIX-Placebo
Arm Type
Placebo Comparator
Arm Description
Physiological Saline (sodium chloride 0.9% (w/v)
Intervention Type
Device
Intervention Name(s)
Visco-ease
Other Intervention Name(s)
RIX - LMS-611x-20, OXB/1-20, LMS-611
Intervention Description
19.6 mg/mL of LMS-611
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% (w/v) Physiological Saline
Intervention Description
Physiological Saline
Primary Outcome Measure Information:
Title
Change in GRIX Score
Description
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.
Time Frame
From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided written informed consent Male or female subjects ≥ 18 years of age 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: Subject is pregnant or breastfeeding Subjects with known allergies to egg, soya, or lanolin (sheep's wool grease) based products 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 Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent 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) Subjects who are unable to independently complete the questionnaire or diary Subjects who are judged inappropriate for inclusion in the study by the CI or PI Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Paterson
Organizational Affiliation
Beatson West of Scotland Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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