Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Patients in the experimental group will be randomized and allocated to two groups: Group 1- BioXtra gel mouthspray® (n = 25) and Group 2- Placebo (n = 25). The vials will be labeled containing only th
Drug
Sponsors
Fundação Antonio Prudente
Faculdade de Odontologia da Universidade de São Paulo
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients older than or equal to 18 years and less than 75 years;patients diagnosed with CPB of oral cavity, oropharynx or nasopharynx; Clinical Stage II or higher;patients submitted to IMRT or RTC3D, between 6 and 12 months, with a minimum dose of 45 Gy in cervicofacial fields and with radio-induced xerostomia.
Exclusion criteria
Exclusion criteria: Patients using cholinergic drugs such as betanecol chloride, pilocarpine and cevimeline;patients with previous history of radiotherapy and / or surgery in the head and neck region;patients submitted to surgery; Patients with metastatic disease;patients who present difficulties in completing the quality of life questionnaire;patients in clinical conditions or impairment of general health status that prevent them from participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction of radiotherapy-induced xerostomia complaint by applying a validated Eisbrush xerostomia questionnaire in Portuguese before product use and 30 days after use. ;To evaluate the enzymatic efficacy of the studied product by biochemical analysis of patients' saliva before use and after 30 days of use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the improvement in patients' quality of life by applying the University of Washington Quality of Life Questionnaire at both stages of the study. | — |
Countries
Brazil
Contacts
Public ContactGraziella Chagas Jaguar
Fundação Antonio Prudente
Outcome results
None listed