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Trial record 6 of 82 for:    611

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02687087
First Posted: February 22, 2016
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lamellar Biomedical Ltd
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde
  Purpose

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.


Condition Intervention
Xerostomia Device: Visco-ease Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • 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.


Enrollment: 44
Actual Study Start Date: March 24, 2016
Study Completion Date: February 2, 2017
Primary Completion Date: February 2, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Visco-ease
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)
Device: Placebo
Physiological Saline
Other Name: 0.9% (w/v) Physiological Saline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687087


Locations
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Lamellar Biomedical Ltd
University of Glasgow
Investigators
Principal Investigator: Claire Paterson Beatson West of Scotland Cancer Centre
  More Information

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02687087     History of Changes
Other Study ID Numbers: GN14ON413
00908 ( Other Identifier: Funder )
44528835 ( Registry Identifier: ISRCTN Registry )
First Submitted: February 17, 2016
First Posted: February 22, 2016
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NHS Greater Glasgow and Clyde:
Radiotherapy Induced Xerostomia (RIX)

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases