Impact of photobiomodulation in the salivary flow of patients treated with radiotherapy and chemotherapy for head and neck cancer: double blind and randomized pilot study.

Not Applicable

• Conditions: Xerostomia; Saliva; Head and neck neoplasms; C07.465.815.929; A12.200.666; C04.588.443

• Registration Number: RBR-5746z9
• Lead Sponsor: Próprio pesquisador

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with cancer of the head and neck (oral cavity, pharynx, larynx and occult primary) with indication of treatment with radiotherapy; Patients that the irradiation field must include all major salivary glands.

Exclusion Criteria

Patients younger than 18 years or incapacitated to answer questions; Initial tumors (T1 and T2) and limited to the larynx, other sites such as metastases and skin tumors; Indication of RT with palliative intent; Patients with Diabetes Melitus, autoimmune, infectious and collagen diseases.
Patients who use drugs that may interfere with the salivary flow; Patients with trismus or limitation of mouth opening due to surgical sequelae.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1<br>It was expected that at D3, one month after the end of radiotherapy, patients belonging to the intervention group would have maintained an unstimulated salivary flow greater than 0.2 ml / min (grade 1) and lower degrees of xerostomia when compared to the placebo group, measured through unstimulated sialometry and the application of the xerostomia inventory.;Outcome found 1<br>The patients in the intervention group maintained an unstimulated salivary flow greater than 0.2 ml / min after one month of radiotherapy. They also maintained lower xerostomy inventory values ??than the control group for one month after completion, indicating less severe xerostomy.

Secondary Outcome Measures

Name	Time	Method
Expected outcome 2<br>It was expected that patients in the intervention group had a lower prevalence of oral complications associated with hyposalivation than patients in the control group.;Outcome found 2<br>A lower prevalence of oral complications associated with hyposalivation (mucositis, fungal infections, dysphagia, oral pain) was observed in the intervention group when compared to the control group, confirming the expected outcome 2.<br>