Skip to content

Pilot clinical study of a Dermatological Preparation for the Prevention of Skin Lesions in patients with Breast Cancer treated with Radiotherapy

Dermatological Preparation to protect the skin of patients with Breast Cancer undergoing Radiotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-973mztk
Enrollment
Unknown
Registered
2025-04-15
Start date
2023-01-01
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 pilot, single-blind, single-arm clinical trial. Experimental group: 25 women aged between 24 and 70 years, diagnosed with breast cancer who were consulted at the “Radiotherapy Service of Con
D27.505.696.706.776

Sponsors

Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo
Lead Sponsor
Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Women aged between 40 years and 70 years; with invasive breast cancer; with pathological staging I – TNM (tumor -T; lymph node - N; metastasis - M) stage T1N0, i.e., unifocal lesion measuring up to 2.0 cm without lymph node involvement through lymph node sampling from the axilla or sentinel lymph node research; patients with therapeutic plans that involve only breast treatment

Exclusion criteria

Exclusion criteria: Women with a history of collagenosis (rheumatological autoimmune diseases); patients with large breasts, that is, with the distance between the sternum and the mid-axillary line greater than 25 cm; patients with therapeutic plans that involve treatments of areas other than the breasts, such as axillary drainage, supraclavicular or internal mammary fossa drainage

Design outcomes

Primary

MeasureTime frame
Protection of the skin that will receive radiation is expected to be found, assessed by clinical examination, so that at most, the appearance of grade 1 radiodermatitis is observed. Data collected at the beginning and weekly, until the end of breast radiotherapy

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactMarli Gerenutti

Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo

marli.gerenutti@gmail.com+55 (15)991550151

Outcome results

None listed

Source: REBEC (via WHO ICTRP)