Three-Arm Randomized Phase III Trial: Quality Aloe and Placebo Cream Versus Powder as Skin Treatment During Breast Cancer Radiation Therapy
| Autor: | Donna Hoopfer, Nirmal Mehta, John Hanson, Barbara Krause, Sunita Ghosh, Keith Tankel, Charlotte King, Diane Severin, Zsolt Gabos, Alan W. Lees, Susan Chafe, Maha Alidrisi, Caroline L. Holloway, Faith M. Strickland |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Administration Topical medicine.medical_treatment Skin Cream Breast Neoplasms Placebo Aloe vera law.invention Breast cancer Double-Blind Method Randomized controlled trial law Dry skin medicine Humans Aloe integumentary system biology Plant Extracts business.industry Middle Aged medicine.disease biology.organism_classification Dermatology Radiation therapy Regimen Oncology Toxicity Female Powders Radiodermatitis medicine.symptom business Phytotherapy |
| Zdroj: | Clinical Breast Cancer. 15:181-190.e4 |
| ISSN: | 1526-8209 |
| DOI: | 10.1016/j.clbc.2014.12.006 |
| Popis: | Background The efficacy of aloe extract in reducing radiation-induced skin injury is controversial. The purpose of the present 3-arm randomized trial was to test the efficacy of quality-tested aloe extract in reducing the severity of radiation-induced skin injury and, secondarily, to examine the effect of a moist cream versus a dry powder skin care regimen. Materials and Methods A total of 248 patients with breast cancer were randomized to powder, aloe cream, or placebo cream. Acute skin toxicity was scored weekly and after treatment at weeks 1, 2, and 4 using a modified 10-point Catterall scale. The patients scored their symptom severity using a 6-point Likert scale and kept an acute phase diary. Results The aloe formulation did not reduce acute skin toxicity or symptom severity. Patients with a greater body mass index were more likely to develop acute skin toxicity. A similar pattern of increased skin reaction toxicity occurred with both study creams compared with the dry powder regimen. Conclusion No evidence was found to support prophylactic application of quality aloe extract or cream to improve the symptoms or reduce the skin reaction severity. Our results support a dry skin care regimen of powder during radiation therapy. |
| Databáze: | OpenAIRE |
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