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Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients


Phase 4
18 Years
90 Years
Not Enrolling
Both
Xerostomia

Thank you

Trial Information

Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients


Inclusion Criteria:



1. The patient must be at least 18 years of age.

2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of
head and neck cancer

3. The patient must understand and consent in writing to the procedure.

Exclusion Criteria:

1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold
values.

2. 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

3. Patients who are unable or unwilling to cooperate with study procedures.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

OHIP questionaire health impact profile

Outcome Description:

Effect on oral health quality will be assessed after each treatment period

Outcome Time Frame:

7 days

Safety Issue:

Yes

Authority:

Sweden: Medical Product Agency

Study ID:

HS-10-404

NCT ID:

NCT01316393

Start Date:

February 2011

Completion Date:

June 2011

Related Keywords:

  • Xerostomia
  • xerostomia, saliva, mucoprotection, oral health
  • Head and Neck Neoplasms
  • Xerostomia

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