Dry mouth, unspecified
Conditions
Interventions
This is a clinical, randomized, controlled, two-arm, single-blind study. Patients will be sequentially randomized and allocated into two groups: Laser Group (n=50) and Placebo Group (n=50). Age and do
Phase 2 (application of the 5 extraoral TFBM sessions)
Phase 3 (10 days after RIT)
Phase 4 (3 months after RIT)
Phase 5 (6 months after RIT)
Phase 6 (1 year after RIT). In phases 1, 3, 4, 5 and 6, the following will be performed: clinical and intraoral examinations, photographic records, evaluation of the stimulated and non-stimulated sali
E02.594
Sponsors
Fundação Antônio Prudente- A.C.Camargo Cancer Center
Fundação Antônio Prudente- A.C.Camargo Cancer Center
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers must be 18 years of age or older; with differentiated thyroid cancer; both sexes; indication of radioiodine therapy after total thyroidectomy surgery
Exclusion criteria
Exclusion criteria: Patients who have received any previous radioiodine therapy or radiotherapy in the head and neck region; patients who underwent thyroidectomy at another institution; previous diseases of the salivary glands; clinical conditions or impaired general health that prevent them from participating in the study; patients who are using bethanechol chloride or any other cholinergic drugs; patients who do not attend at least 4 sessions of photobiomodulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the preventive use of photobiomodulation therapy using unfocused high power extraoral laser will clinically reduce the acute changes related to the salivary glands in patients undergoing radioiodine therapy as an adjuvant treatment of differentiated thyroid cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to identify the glandular profile (stimulated and non-stimulated salivary flow, salivary pH, intensity of xerostomia and hyposalivation) of patients before total thyroidectomy and radioiodine therapy; In addition to analyzing the occurrence of oral complications and acute and late salivary glands in patients undergoing RIT; Evaluate the effectiveness of preventive photobiomodulation to relieve pain and/or edema in the topography of the salivary glands; Positive results are expected in the quality of life of patients undergoing radioiodine therapy using laser; It is expected to identify predictive factors for the occurrence of oral and salivary gland complications by associating the patient's clinical profile and observing the dose used in the treatment. | — |
Countries
Brazil
Contacts
Public ContactGraziella Chagas Jaguar
Fundação Antonio Prudente
Outcome results
None listed