Kong, M., & Hong, S.E. (2013). Topical use of recombinant human epidermal growth factor (EGF)-based cream to prevent radiation dermatitis in breast cancer patients: A single-blind randomized preliminary study. Asian Pacific Journal of Cancer Prevention, 14, 4859–4864.

DOI Link

Study Purpose

To determine if the use of a human epidermal growth factor (EGF)-based cream can prevent radiation dermatitis in patients with breast cancer treated with radiation

Intervention Characteristics/Basic Study Process

Patients with breast cancer needing post-operative radiation randomly were assigned to use human recombinant EGF-based cream (intervention) or general supportive skin care (control). The intervention group applied study cream three times daily to the radiated area from start of treatment through two weeks post-completion of treatment. The control group washed gently with or without mild soap, patting to dry. No cosmetics, perfumes, creams, or lotions were allowed on the treated area in the control arm.

Sample Characteristics

  • N = 40
  • MEAN AGE: Intervention group: 57.3 years (40.2–74.0 years); control group: 51.8 years (36.5–76.1 years)
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Unilateral breast cancer, no skin invasion by tumor, breast-conserving surgery, presence or absence of adjuvant chemotherapy, radiation to minimum dose of 45 cGy without use of bolus
  • OTHER KEY SAMPLE CHARACTERISTICS: No concurrent chemotherapy, rashes, or unhealed wounds in treatment area. No history of previous radiation therapy (RT) to chest wall, connective tissue disorder.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Department of Radiation Oncology, Kyung Hee University Medical Center, Seoul, Republic of Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Single-blind, randomized preliminary study

Measurement Instruments/Methods

Examination of site was completed prior to RT, weekly during RT, and six weeks post-RT. Skin changes were scored using the Radiation Therapy Oncology Group (RTOG) criteria by a radiation oncologist blinded to group assignment. Pain was evaluated with a 10-point visual analog scale. Intervention patients completed a questionnaire regarding ease of cream application at the end of the study.

Results

There was no statistical difference between the intervention and control groups for dermatitis and pain scores. For the total population, maximal dermatitis was 27.5% grade 3, 52.5% grade 2, and 20% grade 1. In the intervention group, maximal dermatitis was 15% grade 3, 55% grade 2, and 30% grade 1. In the control group, maximal dermatitis was 40% grade 3, 50% grade 2, and 10% grade 1. For the total population, mean maximal pain score was 3.13 with a range of 0–7. In the intervention group, mean maximal pain score was 2.80 with a range of 0–6. In the control group, mean maximal pain score was 3.13 with a range of 0–7.

Conclusions

Although there was a difference in the intervention and control groups in terms of grade 3 dermatitis, (15% compared to 40%), there was no statistical difference between the intervention of human recombinant EGF-based cream and the control of supportive skin care. As with previous studies, total RT dose and lymph node radiation were prognostic factors for grade 3 radiation dermatitis. This study did not look at patient-related prognostic factors that potentially contribute to increased radiation dermatitis.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: As with other studies, the RTOG skin toxicity scoring, although utilized by many practices and clinical trials, has not been tested for validity and reliability.

Nursing Implications

There continues to be no “best practice” for prevention and treatment of radiation dermatitis. Practice varies worldwide. Further studies with a large sample size and inclusion of a double-blinding would be useful for this product as several studies have shown with EGF for wound healing.