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Extra and Intraoral Low-Intensity Laser for Prevention and Treatment of Oral Lesions and Dry Mouth in Cancer patients: Double-Blind Randomized Controlled Clinical Study

Extra and Intraoral Photobiomodulation for the Prevention and Treatment of Oral Mucositis and Xerostomia in Cancer patients: a Double-Blind Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5p2xfzd
Enrollment
Unknown
Registered
2023-12-19
Start date
2023-10-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatitis

Interventions

This is a double-blind (participant and evaluator) randomized clinical superiority study. 82 patients will be included in the study. Patients included in the research will be those who are at the begi
SP5.467.522.498
G03.787.297.937

Sponsors

Pontifícia Universidade Católica de Campinas
Lead Sponsor
Pontifícia Universidade Católica de Campinas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years old diagnosed with head and neck cancer will be included; Patients undergoing the first week of radiotherapy and/or chemotherapy with curative intent in the Oncology Sector of Hospital PUC-Campinas in the period from 2023 to 2024; Patients or guardians who agree and sign the Informed Consent Form

Exclusion criteria

Exclusion criteria: Patients who die during treatment (before completing the initially established sessions) will be excluded; Patients who give up oncological treatment before completion; Patients who were not in the first week of radiotherapy and/or chemoradiotherapy; Patients on palliative protocols;Patients with total loss of the maxilla or mandible as a result of the tumor; Patients who are unable to perform sialometry (difficulty spitting saliva); Patients who refuse to sign the Informed Consent Form

Design outcomes

Primary

MeasureTime frame
It is expected that extraoral photobiomodulation (PBM) associated with intraoral photobiomodulation will have a superior behavior than intraoral photobiomodulation in the prevention and treatment of low salivary flow and Oral Mucositis (OM) resulting from the effects of radiotherapy and/or chemotherapy of the head and neck, contributing to an improvement in quality of life. of cancer patients.—

Secondary

MeasureTime frame
To evaluate whether extra and intraoral photobiomodulation is superior to intraoral photobiomodulation in controlling oral mucositis and increasing salivary flow in oncology patients with head and neck cancer.—

Countries

Brazil

Contacts

Public ContactGabriele Brunelli

Pontifícia Universidade Católica de Campinas

gabibrunelli@hotmail.com+55(19)3343-7012

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 4, 2026