NCT02687087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2017

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

February 17, 2016

Last Update Submit

February 17, 2017

Conditions

Xerostomia

Keywords

Radiotherapy Induced Xerostomia (RIX)

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Visco-ease

EXPERIMENTAL

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.

Device: Visco-ease

RIX-Placebo

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

Visco-easeDEVICE

19.6 mg/mL of LMS-611

Also known as: RIX - LMS-611x-20, OXB/1-20, LMS-611
Visco-ease
PlaceboDEVICE

Physiological Saline

Also known as: 0.9% (w/v) Physiological Saline
RIX-Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claire Paterson

    Beatson West of Scotland Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 22, 2016

Study Start

March 24, 2016

Primary Completion

February 2, 2017

Study Completion

February 2, 2017

Last Updated

February 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)