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Light therapy to prevent Oral Mucositis induced by Radiotherapy in patients with head and neck cancer

Preventive photobiomodulation protocol with light-emitting diode (LED) for Oral Mucositis induced by radiotherapy in patients with head and neck cancer: a randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-63xd92g
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-08-01
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

Mucositis

Interventions

Control: 30 patients. A Twin Flex Evolution device (MMOptics, São Paulo, Brazil) will be used, at a wavelength of 660 nm, 625mW / cm2 of power density, 6.2 J / cm2 energy density, 10 seconds per point
E02.594.540

Sponsors

Instituto do câncer do ceará
Lead Sponsor
Faculdade de Odontologia, Farmácia e Enfermagem da Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: individuals over the age of 18 of both sexes who can read and write; who have normal cognition; who have primary neoplastic lesions in the head and neck region; those who will start treatment with radio chemotherapy

Exclusion criteria

Exclusion criteria: patients previously submitted to radiotherapy and / or chemotherapy of the head and neck; patients using drugs that could interfere with oral mucositis; oral cancer patients; use of poorly adapted mobile prostheses that cause mucosal lesions; presence of limited mouth opening (less than 20 mm); cancer lesions associated with UV light; HIV patients; patients with stomatitis or other lesions of the oral cavity; decompensated diabetes; autoimmune disease or any other disease that may affect the healing mechanisms

Design outcomes

Primary

MeasureTime frame
Evaluate the frequency of appearance and degree of oral mucosite, using the method of evaluation and classification of parameters of the World Health Organization (WHO), evaluated indexes before and after application of the laser or LED. An oral mucosite will be considered serious when classified in grades 3 or 4, according to the WHO scale—

Secondary

MeasureTime frame
Analyze quality of life, using the validated version of the University of Washington's Quality of Life Questionnaire (UW-QOL) to assess the quality of life related to the oral health of the participants. There are 12 questions related to specific areas or functions of the head and neck region (activity, recreation, pain, mood and anxiety). Question scores will be scored for pre- and post-intervention analysis—

Countries

Brazil

Contacts

Public ContactKarina Pontes
kamatthes@yahoo.com.br+55-85-986444933

Outcome results

None listed

Source: REBEC (via WHO ICTRP)