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Evaluation of Irradiation over the radial artery with Low-Intensity Laser as a method for controlling Oral Mucositis in patients undergoing Radiotherapy

Evaluation of Transcutaneous Irradiation over the radial artery with Low-Intensity Laser as an additional method for the control of Oral Mucositis in patients undergoing Head and Neck Radiotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8ksffhm
Enrollment
Unknown
Registered
2023-09-22
Start date
2023-06-05
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

Oral Mucositis

Interventions

This is a randomized, double-blind, placebo-controlled clinical trial. 150 will be included in the study patients. Patients included in the study will be randomized into two groups (75 patients in eac
2. Areas with lesion: red laser with a wavelength of 660nm, applied 03 seconds per point, 0.3J in the lesion and around it (with a distance of 2mm from the mucosa). Before the application of the laser
E02.594

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients over 18 years old; diagnosis of head and neck cancer; indication of radiotherapy treatment

Exclusion criteria

Exclusion criteria: Radiotherapy treatment with a dose lower than 50Gy in the primary treatment area; patients with neurological, psychomotor and/or psychiatric disorders; patients with neoplasia in the region to be irradiated; with undiagnosed clinical lesions in the irradiated region; on the skin of patients who make topical use of photosensitive substances; patients with complex arrhythmias and heart failure; patients with hematological neoplasms; patients with uncontrolled glaucoma; cataracts without medical supervision; pregnant patients; patients with tattoos in the region to be applied the laser

Design outcomes

Primary

MeasureTime frame
It is expected to find a clinical and pain reduction in oral mucositis and an improvement in quality of life. Verified using the scale method proposed by the WHO and the criteria recommended by the National Cancer Institute (NCI), as well as the quality of life questionnaire - University of Washington Quality of Life (UW-QOL). We will observe 60% of patients with pain related to MO less than 5 on the EVA visual pain scale and we will observe a 30% reduction in loss of quality of life according to the questionnaire during radiotherapy treatment—

Secondary

MeasureTime frame
Secondary outcomes are not expected—

Countries

Brazil

Contacts

Public ContactMilena Vasconcelos

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

professoramilenarv@gmail.com+55 (16) 3602.1000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)