Jensen, J.M., Gau, T., Schultze, J., Lemmnitz, G., Folster-Holst, R., May, T., . . . Proksch, E. (2011). Treatment of acute radiodermatitis with an oil-in-water emulsion following radiation therapy for breast cancer: A controlled, randomized trial. Strahlentherapie Und Onkologie, 187(6), 378–384.

DOI Link

Study Purpose

To test the hypothesis that treatment with an oil-in-water emulsion (WO1932) leads to more rapid skin hydration, improves skin barrier function, and reduces pruritus in patients after radiation therapy

Intervention Characteristics/Basic Study Process

Patients were randomized to a treatment group or control group. In the treatment group, the oil-in-water emulsion was applied twice a day over six to eight weeks, starting after radiation therapy was completed. Sauna, swimming, and use of any other skin care product were not allowed. Clinical assessment was done after week one and at the end of the study.

Sample Characteristics

  • N = 64
  • AGE: Not provided
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: All were experiencing radiodermatitis with an ONS score of 0–3
     

Setting

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  •  Open-label RCT

Measurement Instruments/Methods

  • ONS skin reaction scoring (not described)
  • Transepidermal water loss
  • Visual analog scale (VAS) for pruritus
     

Results

Pruritus decreased in all patients but more in the treatment group in weeks one, two, three, and five (p < .04). There was no significant difference between groups in skin scores overall. There was no difference between groups in transepidermal water loss.

Conclusions

This study does not provide strong evidence in favor of the oil-in-water emulsion tested here. Findings suggest the emulsion was helpful in reducing pruritus compared to no treatment at all.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding) 
  • Risk of bias(sample characteristics)
  • Measurement/methods not described
  • Other limitations/explanation: In one place, authors report that measures were done after week one and eight yet provide data for multiple other weeks. No demographic information is provided. Inclusion criteria state that patients had 0–3 skin scores, which means, at 0, there was no radiodermatitis. No clear baseline data or comparison of skin scores are provided.

Nursing Implications

This study does not provide strong evidence for evaluation of effectiveness of the oil-in-water emulsion tested here.