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

Phase 3

Recruiting

• Conditions: Radiotherapy, Breast neoplasms, Radiodermatitis, Women; C17.800.174.826; C04.588.180; M01.975; Q65.050

• Registration Number: RBR-784f3y
• Lead Sponsor: Escola de Enfermagem da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>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 Outcome Measures

Name	Time	Method
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.