Hematopoietic stem cell transplantation.
Conditions
Interventions
This is a two-arm, randomized controlled clinical trial with a parallel interventional design, employing a quantitative approach, exploratory character, and open-label blinding. The sample will be col
Sponsors
Complexo do Hospital das Clínicas da Universidade Federal do Paraná (UFPR)
Universidade Federal do Paraná
Eligibility
Age
5 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteer patients aged 5 years or older; of both sexes; regardless of weight, height, race, or social condition; who will begin the Hematopoietic Stem Cell Transplantation (HSCT) protocol due to onco-hematological or hematological diseases.
Exclusion criteria
Exclusion criteria: Patients undergoing autologous transplantation who are under 5 years of age; who use photosensitive medications (tetracycline, sulfonamide, retinoic and glycolic acid); as well as patients who present with elevated core temperature (fever); allergies or any alteration in the skin of the face during treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study aims to evaluate the preventive clinical response of oropharyngeal mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT) using extraoral photobiomodulation therapy (EOPT) and intraoral photobiomodulation therapy (IOPT). | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of mucositis is expected to be assessed using the World Health Organization (WHO) and NCI (National Cancer Institute) scales.;The aim is to evaluate the frequency of oropharyngeal mucositis in patients who received intra- and extraoral TFBM using clinical examination.;Pain levels are expected to be assessed using the Visual Analogue Scale (VAS).;The aim is to evaluate the inflammatory markers present in saliva through the processing and analysis of inflammatory constituents and mediators.;The aim is to evaluate both organic and inorganic salivary constituents.;The aim is to assess the temperature difference in the oral region using thermographic images in areas with and without oropharyngeal mucositis. | — |
Countries
Brazil
Contacts
Public ContactJéssica Noronha
Universidade Federal do Paraná
Outcome results
None listed