A Comparative Study Between Topical Betamethasone Cream or Topical Olive Oil Cream in Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients.

CL 2775

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 treated with radiation. Betamethasone valerate, olive oil cream and the base cream will be compared in a randomized trial to evaluate and compare the development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score, percentage of patients with the maximum observed ARD grade for each arm of the study, percentage of patients with moist desquamation for each arm of the study, percentage of radiodermatitis-free patients at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy). In addition, the patients' quality of life will be evaluated using Dermatology Life Quality Index (DLQI).

2021-11-04

2023-03-01

2023-06-01

Recruiting

Early phase I

132

Inclusion Criteria: * 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 Criteria: * 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.

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2023-02-09