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

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.
 
ClinicalTrials.gov Identifier: NCT02687087
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : February 20, 2017
Sponsor:
Collaborators:
Lamellar Biomedical Ltd
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE February 22, 2016
Last Update Posted Date February 20, 2017
Actual Study Start Date  ICMJE March 24, 2016
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
Change in GRIX Score [ Time Frame: From baseline (Visit 1) to end of treatment (Visit 7) ]
The primary endpoint will be compared between Visco-ease and the Placebo Treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy
Official Title  ICMJE Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Xerostomia
Intervention  ICMJE
  • Device: Visco-ease
    19.6 mg/mL of LMS-611
    Other Names:
    • RIX - LMS-611x-20
    • OXB/1-20
    • LMS-611
  • Device: Placebo
    Physiological Saline
    Other Name: 0.9% (w/v) Physiological Saline
Study Arms  ICMJE
  • 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.
    Intervention: Device: Visco-ease
  • Placebo Comparator: RIX-Placebo
    Physiological Saline (sodium chloride 0.9% (w/v)
    Intervention: Device: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2016)
35
Actual Study Completion Date  ICMJE February 2, 2017
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02687087
Other Study ID Numbers  ICMJE GN14ON413
00908 ( Other Identifier: Funder )
44528835 ( Registry Identifier: ISRCTN Registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NHS Greater Glasgow and Clyde
Study Sponsor  ICMJE NHS Greater Glasgow and Clyde
Collaborators  ICMJE
  • Lamellar Biomedical Ltd
  • University of Glasgow
Investigators  ICMJE
Principal Investigator: Claire Paterson Beatson West of Scotland Cancer Centre
PRS Account NHS Greater Glasgow and Clyde
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP