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Evaluation of a cosmetic for use in patients with Cancer in the prevention and treatment of Dermatitis caused by radiation

Evaluation of an Oncological Cosmetic in the prevention and treatment of Radiodermatitis: a triple-blind randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-44wxphd
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-05-27
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

Radiodermatitis

Interventions

This is a two-arm, triple-blind, randomized controlled clinical study. Experimental group: 38 patients with breast cancer and recommended radiotherapy treatment will receive a cream containing a blend

Sponsors

Instituto do Câncer do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years old; both sexes; diagnosis of breast cancer with indication of adjuvant radiotherapy treatment in the breast region; intact and continuous skin in the target region; first day of radiotherapy treatment (new cases); absence of previous history of radiotherapy in the same field/site of treatment; absence of previous treatment with chemotherapy, acceptance to participate in the research by signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: Have hypersensitivity to one of the components of the research creams; patients with indication for electron radiotherapy; deficit in adhering to the research intervention and following the study guidelines

Design outcomes

Primary

MeasureTime frame
It is expected to evaluate the effectiveness of creams used to prevent radiodermatitis and help prevent its progression. For this purpose, the following methods will be used: CTCAE Scale, in which the radiodermatitis found is expected to reach a maximum of grade 2; Skin analyzer pen, associated with the skin pH meter, to assess the level of hydration and functionality of the skin, expecting to find percentages of water between 40-60%, oil 16-22% and pH between 4.6-5.8

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactLara de Moura

Instituto do Câncer do Ceará

laramoura@alu.ufc.br+55-85-32884478

Outcome results

None listed

Source: REBEC (via WHO ICTRP)