Effect of lotion with grape seed oil at 5% to reduce adverse reactions caused by radiotherapy: randomized clinical trial

Not Applicable

Recruiting

• Conditions: Radiodermatitis; C17.800.174; Breast Neoplasms

• Registration Number: RBR-446wxd6
• Lead Sponsor: Cintia da Silva Marconato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

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

Inclusion Criteria

Female; aged 18 or over; breast cancer; indication of adjuvant or exclusive radiotherapy; with intact skin in the treatment area.

Exclusion Criteria

Palliative radiotherapy; history of irradiation in the same treatment field; bolus use; bilateral irradiation; allergy to lotion with grape seed oil at 5% or the non-ionic base Crodabase CR2; Uncontrolled Diabetes Mellitus; connective tissue diseases.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the time elapsed between the start of radiotherapy and the appearance of radiodermatitis between the intervention (5% grape seed oil lotion) and control (Crodabase CR2 non-ionic base) groups. Using the Criteria Score for Acute Radiation Morbidity scale. According to previous studies about 95% of patients undergoing radiotherapy will have some degree of skin injury during radiotherapy.

Secondary Outcome Measures

Name	Time	Method
To assess the moisture and oiliness of the skin in the treatment area, as well as the quality of life presented by the participants during radiotherapy treatment. Through the Skin Analyzer SKN1501 device and the instruments: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in its third version, which assesses quality of life in general and the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC-BR23), which is the specific module of the instrument for assessing the quality of life of patients with breast cancer.