Effects of Mucoprotective Product on Xerostomia

Camarus

Status and phase: Completed; Phase 4

Conditions: Xerostomia

Treatments: Other: XER2020

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01316393

HS-10-404

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 3 patient groups, including a placebo group

XER2020

Experimental group

Description:

mucoprotective product

Treatment:

Other: XER2020

Saliva Natura

Active Comparator group

Description:

salivary substitute

Treatment:

Other: XER2020

XER2020 placebo

Placebo Comparator group

Treatment:

Other: XER2020