References
Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol
Abstract
Objective:
Little is known about the efficacy of products aiming to prevent radiodermatitis, which affects between 90–95% of women with breast cancer. The use of antioxidants is promising, however, there is a lack of evidenceon their effectiveness. Here, the authors present a clinical trial protocol to evaluate the effects of applying a cream containing nanoparticles with vitamin E to prevent radiodermatitis in patients with breast cancer.
Method:
The protocol recommends that 108 women with breast cancer, receiving radiotherapy, are included in this triple-blinded, randomized, controlled study at an oncology hospital. Patients will be divided in three groups of 36 individuals each: group A will receive a cream with lipid nanoparticles and vitamin E, group B will receive a cream without nanoparticles nor vitamin E, and group C will receive a cream with nanoparticles without vitamin E. The primary endpoints will evaluate the incidence, degree, and time of onset of radiodermatitis. The secondary endpoints will focus on the quality of life, symptoms, and local temperature. Patients will be assessed three times a week, from the start of their radiotherapy treatment to two weeks after the last session. This protocol was approved by the research ethics committee of the institutions involved and registered on an international trials database.
Breast cancer is the second leading cause of death in the world female population.1 In Brazil, the risk of development is 56.3 cases per 100.000 women.2 One of the treatment modalities is radiation therapy, and up to 60% of cancer patients will undergo this treatment at some point.3,4,5
Radiation therapy is characterized by the use of ionizing radiation to affect the environment in which it is applied. It acts on the cell's DNA, preventing it from reproduction and inducing its death through apoptosis.6,7,8 In the case of breast cancer, radiation therapy is used as an adjuvant treatment following a radical mastectomy to decrease the local recurrence rates, and to improve the overall survival (this is, the disease-free time that patients will have after treatment).9
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