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

Effectiveness of 5% grape seed oil lotion for radiodermatitis reduction: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-446wxd6
Enrollment
Unknown
Registered
2022-10-20
Start date
2022-03-01
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

Breast Neoplasms

Interventions

This study aims to evaluate the effectiveness of lotion with grape seed oil at 5% compared to the use of non-ionic base Crodabase CR2 to reduce radiodermatitis in women with breast cancer. Participant
D27.505.519.217
D20.215.784.500.400

Sponsors

Cintia da Silva Marconato
Lead Sponsor
Universidade Federal de Santa Maria
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

Brazil

Contacts

Public ContactTânia Magnago

Universidade Federal de Santa Maria

tania.magnago@ufsm.br+55-055-32208263

Outcome results

None listed

Source: REBEC (via WHO ICTRP)