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Evaluation of microcirculation of the oral mucosa in patients undergoing chemotherapy and radiotherapy

Evaluation of microcirculation of the oral mucosa using laser doppler flowmetry in patients receiving chemotherapy and radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-2499jt
Enrollment
Unknown
Registered
2020-07-02
Start date
2019-01-21
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

Head and Neck Neoplasms

Interventions

Assessments in patients before the start of chemotherapy and radiotherapy and during treatments, in 7 moments in the chemotherapy group (7 patients) and 8 moments in the radiotherapy group (10 patient
Device

Sponsors

Universidade de São Paulo - Campus Bauru
Lead Sponsor
Universidade de São Paulo - Campus Bauru
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Diagnosis of malignant tumor; Therapeutic regimen associated with high risk of developing oral mucositis; Standard chemotherapy and or head and neck radiation therapy; Age over 18 years; Control group healthy individuals

Exclusion criteria

Exclusion criteria: Pregnancy; Diabetic; Patients with uncontrolled systemic arterial hypertension

Design outcomes

Primary

MeasureTime frame
It is expected to find that changes in blood flow generate a greater incidence of oral mucositis and greater pain intensity in the groups studied through the laser doppler flowmetry method. ;Using the laser doppler flowmetry method, it was observed that there was a change in blood flow in the chemotherapy and radiotherapy group in all evaluations after the start of antineoplastic treatments. In the chemotherapy group, the lowest flow occurred between 7 and 9 days (3rd evaluation) and coincided with the most severe manifestation of oral mucositis on both scales and with the greatest pain intensity. In the radiotherapy group there was also a coincidence between the lowest flow in the 4th week (4th evaluation) with the most severe manifestation of oral mucositis and with the highest pain intensity. Blood flow was similar when compared to the chemotherapy, radiotherapy and control groups; before treatments start. The Kruskal-Wallis statistical test was used to compare blood flow between the chemotherapy, radiotherapy and control groups in the first evaluation, that is, before the start of antineoplastic treatments, the Friedman test was used to compare the first evaluation (moment baseline) with the other assessments throughout the treatments in the study groups and the Spearmann test was applied to assess the correlation of the variables with each other. For all cases, a significance level of 5% was adopted.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactPaulo Santos

Universidade de São Paulo - Campus Bauru

paulosergiosilvasantos@gmail.com+55-14-32266113

Outcome results

None listed

Source: REBEC (via WHO ICTRP)