Radiation Dermatitis Clinical Trial
Official title:
Phase III Trial Comparing Best Supportive Care to Aloe Vera Gel as a Prophylactic Agent for Radiation Induced Skin Toxicity
Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years.
Although initially used for the treatment of chest wall recurrences after mastectomy and for
advanced inoperable disease, RT has evolved into a critical component of early therapy for
women with an intact breast following lumpectomy and for mastectomized women who are at high
risk for local failure. Currently breast cancer patients need a multidisciplinary management
including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in
loco regional control of the disease. It is estimated that 87% of these women will develop
some degree of radiation-induced dermatitis, varying from mild to brisk erythema or even
moist desquamation.
Topical agents, such as corticosteroid creams and other products including Aquaphor
(Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly
prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning
of radiotherapy.
The aim of this randomized phase III study was to assess the effectiveness of aloe vera
cream for the prevention of acute radiation-induced dermatitis of grade 2 or higher during
postoperative radiotherapy for breast cancer, compared to best supportive care. The
secondary objectives were to assess pain, treatment interruption as a result of skin
reactions, and the quantity of life during the treatment.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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