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Evaluation of laser in the prevention of Mucositis in patients with head and neck Cancer

Evaluation of a Laser Photobiomodulation protocol on the prevention of Mucositis in patients with head and neck Cancer: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4hbxk9k
Enrollment
Unknown
Registered
2024-10-23
Start date
2024-04-15
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

Radiotherapy session

Interventions

This is a blind randomized clinical trial with the aim of evaluating the effect of two weekly irradiations of photobiomodulation (PBM) with low-intensity laser on the development of mucositis in patie
E02.594.540

Sponsors

Universidade Federal do Amazonas
Lead Sponsor
Fundação Centro de Controle de Oncologia do Estado do Amazonas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years or over; with a definitive diagnosis of head and/or neck cancer (lip, oral cavity and pharynx) determined by biopsy; who have started antineoplastic therapy no more than 24 hours before the first laser irradiation; whose antineoplastic treatment will consist of a total dose of RT 70 Gy, with a minimum dose of 50 Gy administered and chemotherapy with cisplatin weekly (30 to 40 mg/m2) and every 21 days (100 mg/m2)

Exclusion criteria

Exclusion criteria: Patients previously irradiated in the head and neck region; patients with metastasis; patients with any interruption of treatment; patients who are unable to attend appointments; patients undergoing unilateral irradiation of the head and neck; patients undergoing surgical resection of the facial nerve and/or its branches; patients with trismus

Design outcomes

Primary

MeasureTime frame
It is expected to observe an Incidence of Mucositis Grades 3 and 4 not lower than the control group

Secondary

MeasureTime frame
It is expected to find a pain intensity and improvement in quality of life not inferior to the control group

Countries

Brazil

Contacts

Public ContactErivan Gualberto Júnior

Universidade Federal do Amazonas

erivangualberto@ufam.edu.br+55-92-992027234

Outcome results

None listed

Source: REBEC (via WHO ICTRP)