Ulff, E., Maroti, M., Serup, J., & Falkmer, U. (2013). A potent steroid cream is superior to emollients in reducing acute radiation dermatitis in breast cancer patients treated with adjuvant radiotherapy. A randomised study of betamethasone versus two moisturizing creams. Radiotherapy and Oncology, 108, 287–292.  

DOI Link

Study Purpose

To determine if treatment with betamethasone+Essex® cream can decrease acute radiation dermatitis in patients with breast cancer receiving radiation as compared to two emollient creams.

Intervention Characteristics/Basic Study Process

Patients with breast cancer receiving radiation therapy were randomized 2:1:1 to three treatment groups—betamethasone+Essex cream, Essex cream, or Canoderm® cream. Study creams were applied to the treated skin twice daily for five weeks starting the first week. Treatment continued for two weeks following completion of radiation. Physician/nurse examinations occurred weekly for the first five weeks of treatment.

Sample Characteristics

  • N = 102  
  • MEDIAN AGE = 62 years
  • AGE RANGE = 28–90 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Surgery for breast cancer, planned 3D radiation to 50 Gy
  • OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Ryhov County Hospital, Jonkoping, Sweden

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, double-blinded

Measurement Instruments/Methods

The Fitzpatrick skin type scheme I–IV  was used to classify patients as to skin type. Radiation dermatitis was scored using the Radiation Therapy Oncology Group (RTOG) scoring system. A colorimeter measured the redness of the skin at specific areas around the areola. Dryness of skin was measured using a Corneometer®, with scores averaged using five specific locations. Itching, burning, and skin irritation were patient-scored using a visual analog scale (VAS) of 0–10. Quality of life was determined via the Dermatology Life Questionnaire Index on the first and fifth weeks of treatment. Post-radiation follow-up was by phone with symptoms assessed using VAS.

Results

Significant difference in RTOG skin reaction scoring was noted at week four (p = 0.003) and week five between the betamethasone+Essex cream (investigational group) and two groups treated with moisturizers (control groups). Colorimetry values were not statistically significant but trended with RTOG scores. Corneometer measurements for dry skin were not detectable in any group. In the control groups, Canoderm cream provided improved skin hydration as compared to Essex cream (p = 0.001). Although all groups had worsening itching, burning, and irritation as radiation continued, statistical significance favored the betamethasone group over the control groups (p = 0.048). Patients with skin type I had more pronounced grade 3 reactions, but less in those treated with betamethasone+Essex than controls. Patients with skin type I at week five on the betamethasone+Essex arm had better effect of treatment (p = 0.01). For patients treated to the fossa and/or axilla, RTOG scoring was significantly different for grade 3 occurrence in the betamethasone+Essex arm than controls (p = 0.008). Patients undergoing radiation following mastectomy in the control arms had significantly higher RTOG scores in week five than those in the betamethasone+Essex arm (p < 0.03).

Conclusions

This study found that prophylactic treatment with betamethasone cream was superior to moisturizing cream for control of acute radiation dermatitis. Because prolonged treatment with topical steroids is known to be able to harm skin integrity, use was limited to seven weeks.

Limitations

  • Measurement validity/reliability questionable
  • Other limitations/explanation: RTOG scoring of skin toxicity has not been tested for validity and reliability.

Nursing Implications

Because up to 90% of patients with breast cancer treated with adjuvant radiation have some degree of skin reaction, assessing and treating according to evidence-based practices is important. This study shows use of prophylactic steroid cream to reduce the severity of skin reaction in this group of patients.