Effects of Mucoprotective Product on Xerostomia
Primary Purpose
Xerostomia
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
XER2020
Sponsored by
About this trial
This is an interventional supportive care trial for Xerostomia focused on measuring xerostomia, saliva, mucoprotection, oral health
Eligibility Criteria
Inclusion Criteria:
- The patient must be at least 18 years of age.
- The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
- The patient must understand and consent in writing to the procedure.
Exclusion Criteria:
- Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
- Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
- Patients who are unable or unwilling to cooperate with study procedures.
Sites / Locations
- Department of Prosthetic Dentistry, Malmö University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
XER2020
Saliva Natura
XER2020 placebo
Arm Description
mucoprotective product
salivary substitute
Outcomes
Primary Outcome Measures
OHIP questionaire health impact profile
Effect on oral health quality will be assessed after each treatment period
Secondary Outcome Measures
Full Information
NCT ID
NCT01316393
First Posted
March 15, 2011
Last Updated
November 8, 2011
Sponsor
Camurus AB
Collaborators
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01316393
Brief Title
Effects of Mucoprotective Product on Xerostomia
Official Title
Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camurus AB
Collaborators
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
xerostomia, saliva, mucoprotection, oral health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XER2020
Arm Type
Experimental
Arm Description
mucoprotective product
Arm Title
Saliva Natura
Arm Type
Active Comparator
Arm Description
salivary substitute
Arm Title
XER2020 placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
XER2020
Intervention Description
mucoprotective product
Primary Outcome Measure Information:
Title
OHIP questionaire health impact profile
Description
Effect on oral health quality will be assessed after each treatment period
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must be at least 18 years of age.
The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
The patient must understand and consent in writing to the procedure.
Exclusion Criteria:
Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
Patients who are unable or unwilling to cooperate with study procedures.
Facility Information:
Facility Name
Department of Prosthetic Dentistry, Malmö University
City
Malmö
ZIP/Postal Code
SE-21421
Country
Sweden
12. IPD Sharing Statement
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Effects of Mucoprotective Product on Xerostomia
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