Evensen, J. F., Bjordal, K., Jacobsen, A. B., Løkkevic E. & Tausjø, J. E. (2001). Effects of Na-sucrose octasulfate on skin and mucosa reactions during radiotherapy of head and neck cancers--a randomized prospective study. Acta Oncologica, 40, 751–755.

Study Purpose

To evaluate the protective effects of Na-sucrose octasulfate (NaSOS) on radiation-induced skin damage in patients with head and neck cancer.

Intervention Characteristics/Basic Study Process

Each patient was his or her own control. NaSOS was applied on one side, and the placebo was applied to the other. It was started on day 1 of radiation therapy (RT) treatment. The gel was applied twice a day during RT and for two weeks after.
 

Sample Characteristics

  • The sample was comprised of 60 patients (20 females, 40 males).
  • Mean age was 60 years (range 21–81).
  • Patients had head and neck cancer.
  • Megavoltage was 4 to 6 MV.
  • There were two opposing lateral portals with separate anterior low neck portals, 2 Gy per fraction, to a total dose of 50 to 70 Gy. Mean total dose was 59.7 Gy.

Setting

Norway

Study Design

The study used a quasiexperimental, double-blind, vehicle-controlled design. Each patient was his or her own control.

Measurement Instruments/Methods

  • Assessments were performed at initiation and weekly.
  • European Organisation for Research and Treatment of cancer (EORTC)/Radiation Therapy Oncology Group (RTOG) acute skin reaction scoring system was used for skin reactions and for pain and itching on both sides.

Results

  • The mean skin reaction grade was higher where the placebo was used (p = 0.02).
  • There were no differences between groups in other variables or the timing of skin reaction development.
     

Conclusions

There was no significant protective effect with use of NaSOS.

Limitations

  • The authors did not specify who performed evaluations, and there was no interrater reliability.
  • There was no log for validation of compliance with study protocol.
  • Other skin care regimens are uncertain.
  • The study had a relatively small sample size.