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Completed

NCT Number: NCT02687087

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

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.

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beatson West of Scotland Cancer Centre

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visco-ease

Device

19.6 mg/mL of LMS-611

Other names: RIX - LMS-611x-20, OXB/1-20, LMS-611

PLACEBO

Device

Physiological Saline

Other names: 0.9% (w/v) Physiological Saline

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • Lamellar Biomedical Ltd
  • University of Glasgow

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2016
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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