Status:
COMPLETED
Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients
Lead Sponsor:
Cairo University
Conditions:
Radiodermatitis; Acute
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This study aims to compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis (ARD) in breast cancer patients t...
Detailed Description
Aim of the study: * This study will be conducted to compare the efficacy of topical steroid cream and topical olive oil cream instituted from the start of radiotherapy in the prevention of acute radi...
Eligibility Criteria
Inclusion
- Histological confirmation of breast malignancy,
- Surgical intervention for carcinoma of the breast with or without lymph node metastasis.
- Treatment with planned course of radiation therapy 5 days a week for 3-6 weeks.
- Good Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1).
- Total radiation dose of ≥42 Gy.
Exclusion
- Pregnant and lactating mothers.
- Previous radiation to the chest or breast area.
- Concomitant chemotherapy.
- Concomitant medication that may cause skin reactions.
- Use of any other product on the skin at the treatment site at any time of the study.
- Active dermatitis, history of autoimmune and connective tissue diseases, skin inflammatory diseases or any other specific skin disease.
- Treatment with local or oral corticosteroid, or antioxidant medications.
- Allergy to olive oil.
- Inflammatory carcinoma of the breast as well as those with a known allergy to olive oil.
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05285943
Start Date
November 4 2021
End Date
January 31 2024
Last Update
February 12 2025
Active Locations (1)
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1
Ain Shams University Hospitals
Cairo, Egypt