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Treatment for dry mouth sensation in patients after radiotherapy of head and neck

Treatment for xerostomia in patients after head and neck radiotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4smhk6
Enrollment
Unknown
Registered
2020-09-11
Start date
2019-04-03
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

Pathological conditions, signs and symptoms

Interventions

Experimental group: 40 patients with oral and oropharyngeal cancer submitted to radiotherapy, with ended therapy for more than 3 months, will use a gel with humectant properties, 5 times a day, passin
Drug
Procedure/surgery
Radiation
Other
L01.178.682.192.836.535.310
E01.370.350.600.631
Q10.020
V03.175.250
E01.370.350.700.225

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - HCFMRP/USP
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - HCFMRP/USP
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Men; Women; over 18 years old; history of oral cavity neoplasm treated with radiotherapy for more than 3 months and less than 2 years after termination

Exclusion criteria

Exclusion criteria: Sjogren's Syndrome; Graft versus Host Disease (GVHD); Hepatitis B and C; HIV; Sarcoidosis; other diseases of the connecting tissues; physical or mental illness at the time of the examination;

Design outcomes

Primary

MeasureTime frame
Is expected to improve the perception of xerostomia reported by the patient before the start of the study ;Is expected reduction of the incidence of candidosis in the gel group with the hydration formula;Positive repercussions are expected regarding the function of swallowing and the possible improvement in taste and smell;The Wilcoxon non-parametric tests with paired Bonferroni and Mann-Whitney correction will be used to analyze the differences found between groups A and B at all times by analyzing the domains related to quality of life UWQOLQ and perception of xerostomia XI. exact Chi-square (X2) will be used for comparison between groups in the socio-demographic domains. Friedman's non-parametric test will be used to compare the values ??obtained in the non-stimulated salivary flow and pH. All analyzes adopted a level of significance greater than p greater than 0.05

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactComitê de ;Gabriela Pesquisa;de Araujo

Universidade de São Paulo - Ribeirão Preto;Universidade de São Paulo - Ribeirão Preto

cep@hcrp.usp.br;gsaraujo@hcrp.usp.br+ 55 016 3633-1144;+55 016 988002243

Outcome results

None listed

Source: REBEC (via WHO ICTRP)