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
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.