Graham, P., Browne, L., Capp, A., Fox, C., Graham, J., Hollis, J., & Nasser, E. (2004). Randomized, paired comparison of no-sting barrier film versus sorbolene cream (10%
glycerine) skin care during post mastectomy irradiation. International Journal of Radiation Oncology, Biology, Physics, 58, 241–246.

DOI Link

Study Purpose

To test the effect of prophylactic 3M Cavilon no-sting barrier film (no-sting) on the rates of moist desquamation compared with sorbolene cream (10% glycerin).

Intervention Characteristics/Basic Study Process

The chest wall was divided into medial and lateral halves, with one half treated with no-sting and the other with sorbolene. No-sting was applied by the nursing staff. Administration began at the start of radiation therapy until two weeks after completion. When a moist desquamation occured, the skin care changed to hydrocolloid dressing.

Sample Characteristics

  • The study sample (N = 61) was comprised of female patients with breast cancer.
  • Mean age was 58 years, with a range of 30–88 years.
  • Thirty-seven patients received chemotherapy, 13 concurrently and 24 sequentially.
  • Radiation therapy used a 6 MV photon beam at a dosage of 50 Gy applied tangentially in 25 fractions.

Setting

The study took place across multiple sites in Sydney, Australia.

Study Design

The study used a quasi-experimental design with patients as their own control.

Measurement Instruments/Methods

  • Patients were assessed from week 1–12.
  • The Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer skin scoring assessment was done weekly.
  • A five-point Likert scale was used to measure pain and pruritus for each area of the skin.

Results

  • Skin dosimetry data in the nonbolus area confirmed that no difference was present in the buildup effect (or lack thereof) between sorbolene and no-sting in those areas outside the skin covered with the bolus material.
  • For skin reaction score (p = 0.005) and pruritus (p = 0.011) the no-sting scores were less.
  • No evidence was found of a statistically significant trend in the relationship to pain scores or analgesia requirements.
  • Nine patients required analgesics for skin reaction in the sorbolene group and eight patients in the no-sting.
  • The cost and nursing time was relatively the same per patient, but the peak skin reactions occurred several weeks after radiation therapy was completed.
  • Two patients in the no-sting group had treatment delays because of pruritus.

Conclusions

No-sting may be beneficial in the mitigation of skin toxicity with radiation therapy.

Limitations

  • The study did not provide a control group without alternative treatment for comparison.
  • In longitudinal follow-up at six weeks data analysis, they included cases for which it was stated that no data was available. It was not clear how these were handled.
  • Initial cost of the product showed that no-sting was more expensive.
  • There was no subgroup analysis based on concurrent chemotherapy.
  • The sample size was small given the variability in patient treatment regimens.