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, 619–626.

To compare the effectiveness of three products in reducing the 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 radiation therapy (RT) 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 their home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of the observations.

• The sample was comprised of 208 women. 
• Mean age across all groups ranged from 54 to 56 years.
• Patients had stage 1 and 2 breast cancer.
• Median dose was 200 cGy daily, and total dose was 6200 cGy most often.
• The average number of treatments was 31.

• Single site 
• Outpatient  
• Duke

Patients were undergoing the active antitumor treatment phase of care.

The study was a double-blind, placebo-controlled, randomized, four-group trial.

• Radiation Therapy Oncology Group (RTOG) skin toxicity scoring
• Patient journal of application, satisfaction, and ease of use

Of the patients, 95% had a skin reaction, with most occurring by week 4. No product tested showed a significant difference in reducing the incidence of grade 2 to 4 skin toxicity compared to placebo. Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reactions were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study.

 No product tested was better than placebo in reducing the incidence of grade 2 to 4 radiodermatitis.

Biafine, Aquaphor, and radiacare gel were no more effective than placebo in reducing the incidence of clinically relevant skin toxicity with RT in patients with breast cancer. Biafine was associated with the greatest increase in toxicity across groups. Findings suggested that none of these products are effective, although a systematic review and meta-analysis in this area suggests that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.