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Use of a substance to prevent and control mouth inflammation caused by radiotherapy

Use of Glutamine in the prevention and control of Radio Induced Oral Mucositis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-9yrnbg
Enrollment
Unknown
Registered
2019-10-29
Start date
2010-10-16
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

Stomatitis

Interventions

The sample will be composed of 17 patients, divided into two groups: Group I (test group) will receive 2g of glutamine diluted in 15ml of saline and Group II (control group) will use 15ml of 0.9% sali
Drug

Sponsors

Universidade Estadual da Paraíba
Lead Sponsor
Daliana Queiroga de Castro Gomes
Collaborator

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients of both sexes; regardless of ethnicity; over 18 years of age; undergoing head and neck radiotherapy with at least half of the oral mucosa area included in the radiation fields.

Exclusion criteria

Exclusion criteria: Patients submitted to palliative RT; those who could not open their mouths; and those who used prophylactic topical drugs or mouth rinse; and those who presented Karnofsky Performance Status<70 were excluded; Interruption of use for just one day and not coming to the dental evaluation resulted in the elimination of the patient from the study.

Design outcomes

Primary

MeasureTime frame
Expected to meet 25% of group I patients developed grade 2 mucositis, while no group II was found in 88.9% of patients; The difference between the two groups being statistically significant (p = 0.003).

Secondary

MeasureTime frame
In group I, the occurrence of grade 2 mucositis decreased over the weeks of radiotherapy, while in group II, the grade 1, 2 and 3 mucositis increased during these weeks.

Countries

Brazil

Contacts

Public ContactDaliana Queiroga de Castro Gomes

Universidade Estadual da Paraíba

dqcgomes@hotmail.com+55 83 33153471

Outcome results

None listed

Source: REBEC (via WHO ICTRP)