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Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol.
- Source :
-
Journal of wound care [J Wound Care] 2021 Jun 01; Vol. 30 (Sup6), pp. S44-S50. - Publication Year :
- 2021
-
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.<br />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.
- Subjects :
- Administration, Cutaneous
Administration, Topical
Clinical Protocols
Female
Humans
Nanoparticles therapeutic use
Ointments
Quality of Life
Randomized Controlled Trials as Topic
Treatment Outcome
Vitamin E therapeutic use
Breast Neoplasms radiotherapy
Nanoparticles administration & dosage
Radiation-Protective Agents administration & dosage
Radiodermatitis prevention & control
Vitamin E administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 0969-0700
- Volume :
- 30
- Issue :
- Sup6
- Database :
- MEDLINE
- Journal :
- Journal of wound care
- Publication Type :
- Academic Journal
- Accession number :
- 34120463
- Full Text :
- https://doi.org/10.12968/jowc.2021.30.Sup6.S44