Gosselin, T.K., Schneider, S.M., Plambeck, M.A., & Rowe, K. (2010). A prospective randomized, placebo-controlled skin care study in women diagnosed with breast cancer undergoing radiation therapy. Oncology Nursing Forum, 37(5), 619–626.doi: 10.1188/10.ONF.619-626
To compare the effectiveness of three different products in reducing incidence of radiodermatitis
Women were randomly assigned to placebo (sterile water mist), Aquaphor, Biafine or RadiaCare gel. Patients were instructed to apply the product two times daily with the start of radiotherapy and until treatment was complete. Patients were not to use any other skin care product on the affected area. The radiation nurse assessed patients weekly and reminded them to complete home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of observations.
The study took place in an outpatient setting at Duke University.
Patients were undergoing active antitumor treatment.
The study used a double-blind placebo-controlled randomized four-group trial design.
Ninety-five percent of patients had a skin reaction, with most occurring by week 4. None of the products tested showed a significant difference to reduce the incidence of grade 2–4 skin toxicity compared to placebo. Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reaction were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study. Biafine was associated with the greatest increase in toxicity across groups.
None of the products tested here were better than placebo in reducing incidence of grade 2–4 radiodermatitis.
Findings suggest that none of these particular products are effective, although a systematic review and meta-analysis in this area suggest that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.