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Use of Vitamin E Cream for Prevention of Skin Lesions in Women with Breast Cancer who undergo radiotherapy

Topical Application of Nanoparticles containing Vitamin E for Prevention of Radiodermatitis in Women with Breast Cancer: Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-784f3y
Enrollment
Unknown
Registered
2017-12-18
Start date
2017-09-11
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

Radiotherapy, Breast neoplasms, Radiodermatitis, Women

Interventions

The sample will be composed of 42 patients divided into three study groups by random allocation - randomization - (each group will consist of 14 patients). Group A - experimental: 14 women with breas
use of soft and wide programs
protecting an irradiated area of ??irritants, avoiding the use of deodorants, perfumes and cosmetics
avoid depilation and, if necessary, use electric tricotomizer apparatus
keep a radiated skin dry and use soft battles
avoid swimming in lakes, swimming pools, sea and use of hot tubs and saunas
avoid the use of ribbons, adhesives and thermal compresses (cold or hot) over an irradiated area
avoid sun exposure in the irradiated area
avoid the use of topical prod
Drug
H01.603.600

Sponsors

Escola de Enfermagem da Universidade de São Paulo
Lead Sponsor
Santa Casa de Misericórdia de Passos
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: be 18 years or older; and present the entire skin on the day radiotherapy begins.

Exclusion criteria

Exclusion criteria: previous radiotherapy in the same area; previus radical mastectomy; be pregnant; have a malignant fungating wound in the irradiated area; report history of adverse reaction to components of the cream formula; be on concomitant chemotherapy; use concomitant topical or systemic anti-inflammatory therapy; collagen diseases such as systemic lupus erythematosus and scleroderma; receive another type of intervention to prevent radiodermatitis, not included in the standard or experimental protocol; and refuse to participate in the study.

Design outcomes

Primary

MeasureTime frame
Reduction in the incidence of radiodermatitis during the entire radiotherapy treatment, verified in clinical reassessments that will be performed three times a week, from the first day of the session to the 14th day after the last session (two weeks after). Reduction in the intensity (degree) of radiodermatitis developed by the patients during the entire radiotherapy treatment, evaluated by the RTOG - Radiation Therapy Oncology Group, from 0 to 4; clinical reevaluations that will be performed three times a week, from the first day of the session to the 14th day after the last session (two weeks after).

Secondary

MeasureTime frame
Quality of life at the beginning and at the end of radiotherapy, assessed by means of a quality of life questionnaire - EORTC-QLQ-30 (EORTC Quality of Life Questionnaire) and the quality of life assessment questionnaire for patients with breast cancer - EORTC-QLQ-BR23 (EORTC Quality of Life Questionnaire - Breast Cancer). Both questionnaires will be applied on the first day of radiotherapy session and after the end of radiotherapy treatment.

Countries

Brazil

Contacts

Public ContactFernanda Schmidt

Escola de Enfermagem da Universidade de São Paulo

fernandamqueiroz@yahoo.com.br55 35 999118288

Outcome results

None listed

Source: REBEC (via WHO ICTRP)