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Randomized Controlled Trial
. 2020 Oct 19:28:e3363.
doi: 10.1590/1518-8345.3953.3363. eCollection 2020.

Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil

[Article in English, Portuguese, Spanish]
Andrea Bezerra Rodrigues  1 , Maria Isis Freire De Aguiar  1 , Patrícia Peres De Oliveira  2 , Naiana Pacifico Alves  1 , Renan Alves Silva  3 , Willame De Oliveira Vitorino  1 , Thays Silva De Souza Lopes  1
Affiliations
Randomized Controlled Trial

Effect of cryotherapy in preventing mucositis associated with the use of 5-fluorouracil

[Article in English, Portuguese, Spanish]
Andrea Bezerra Rodrigues et al. Rev Lat Am Enfermagem. .

Abstract
in English, Portuguese, Spanish

Objective: to evaluate the effect of oral cryotherapy compared to physiological serum on the development of oral mucositis in outpatient cancer patients using the 5-fluorouracil antineoplastic agent.

Method: this is a controlled, randomized, double-blind, and multi-center clinical trial, conducted with 60 patients undergoing chemotherapy. The experimental group (n=30) used oral cryotherapy during the infusion of the 5-FU antineoplastic agent, while the control group (n=30) performed mouthwash with physiological serum at their homes. The oral cavity of the participants was assessed at three times: before randomization, and on the 7th and 14th days after using 5-FU. For data analysis, descriptive analyses and the ANOVA, paired t, and McNemar tests were used.

Results: there was no statistically significant difference between the experimental and control groups in the assessments regarding the grade of mucositis. However, cryotherapy presented the chance to reduce the presence of intragroup mucositis, between the first and second assessments (p=0.000126).

Conclusion: cryotherapy did not obtain statistical significance in relation to oral hygiene with serum, but it proved to be effective intragroup. Record number: RBR-4k7zh3.

Objetivo:: avaliar o efeito da crioterapia oral em comparação ao soro fisiológico no desenvolvimento de mucosite oral em pacientes oncológicos ambulatoriais em uso de antineoplásico 5-fluorouracil.

Método:: trata-se de um ensaio clínico controlado, randomizado, duplo-cego, multicêntrico, realizado com 60 pacientes em tratamento quimioterápico. O grupo experimental (n=30) fez uso de crioterapia oral durante a infusão do antineoplásico 5-FU, ao passo que o grupo controle (n=30) realizou bochechos com soro fisiológico em domicílio. A cavidade oral dos participantes foi avaliada em três momentos: antes da randomização, no 7° dia e no 14° dia após o uso do 5-FU. Para a análise dos dados, utilizaram-se análises descritivas e os testes ANOVA, t pareado e McNemar.

Resultados:: não houve diferença estatística significante entre os grupos experimental e controle nas avaliações quanto ao grau de mucosite. No entanto, a crioterapia teve a chance de reduzir a presença de mucosite intragrupo, entre a primeira e segunda avaliação (p=0,000126).

Conclusão:: a crioterapia não obteve significância estatística em relação à higiene oral com soro, porém se mostrou efetiva intragrupo. Número de registro: RBR-4k7zh3

Objetivo:: evaluar el efecto de la crioterapia oral, comparándola con el suero fisiológico, sobre el desarrollo de mucositis oral en pacientes ambulatorios con cáncer en tratamiento con el antineoplásico 5-fluorouracilo.

Método:: se trata de un ensayo clínico controlado, aleatorizado, a doble ciego y multicéntrico, realizado con 60 pacientes en tratamiento de quimioterapia. El grupo experimental (n=30) utilizó crioterapia oral durante la administración del agente antineoplásico 5-FU, mientras que el grupo control (n=30) realizó enjuagues con suero fisiológico en su domicilio. La cavidad oral de los participantes se evaluó en tres momentos: antes de la aleatorización, y al 7º y 14º día después de la administración de 5-FU. Para el análisis de los datos, se utilizaron análisis descriptivos y las pruebas ANOVA, t pareada y McNemar.

Resultados:: en lo que respecta al grado de mucositis, no se registraron diferencias estadísticamente significativas entre el grupo experimental y el de control en las evaluaciones. Sin embargo, la crioterapia exhibió la posibilidad de reducir la presencia de mucositis intragrupo entre la primera y la segunda evaluación (p=0,000126).

Conclusión:: la crioterapia no alcanzó significancia estadística en comparación con la higiene oral con suero. Sin embargo, demostró ser efectiva intragrupo. Número de registro: RBR-4k7zh3

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Figures

Figure 1
Figure 1. Flow diagram of the study. Fortaleza, CE, Brazil, 2018
*EG = Experimental Group; †CG = Control Group
See this image and copyright information in PMC

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