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Application of ice in the oral cavity of people using chemotherapy for cancers with 5-fluorouracil: a randomized clinical trial

Cryotherapy applied to people using antineoplastic chemotherapy with 5-fluorouracil: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4k7zh3
Enrollment
Unknown
Registered
2017-09-29
Start date
2016-09-20
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

Mucositis

Interventions

Experimental group: 30 patients will be given oral cryotherapy (ice-mouthed) for a total of 35 minutes, starting 5 minutes before the application of 5-FU and lasting for thirty minutes during the infu
Other
E02.258

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Centro Regional Integrado de Oncologia
Collaborator
Ambulatório de quimioteraia do Hospitaversitário Walter Cantidiol Uni
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with cancer receiving chemotherapy 5-fluorouracil (5-FU) bolus as part of chemotherapy protocol at the beginning of treatment (any cycle); Patients over the age of 18;Both sexes;Patients with scores on the Glasgow scale equal to 15.

Exclusion criteria

Exclusion criteria: Be in radiotherapy in the head region or concomitant esophagus to chemotherapy;Possess smoking habits and alcohol during the research;Have a history of tooth sensitivity.

Design outcomes

Primary

MeasureTime frame
Primary outcome is the decrease in the degree of mucositis within 7 days after the application of the 5-fluorouracil chemotherapy measured by the Mucositis Scale of the World Health Organization (WHO) from the observation of a variation of at least 5% in the pre-measurement and post intervention.

Secondary

MeasureTime frame
Secondary outcome is the decrease in the degree of mucositis within 14 days after the application of the 5-fluorouracil chemotherapy measured by the Mucositis Scale of the World Health Organization (WHO) from the observation of a variation of at least 5% in the pre-measurement and post intervention.

Countries

Brazil

Contacts

Public ContactAndrea Rodrigues

Universidade Federal do Ceará

andreabrodrigues@gmail.com558533668454

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 19, 2026