Discussion
toxicity, pain, head and neck cancer, dermatitis, skin toxicity, cutaneous inflammation
DISEASE, HEAD AND NECK CANCER, BLIND, DERMATITIS, SKIN TOXICITY
To our knowledge, this is the first study to identify the prophylactic effect of Sanyrene- a liquid dressing with linoleic acid and linolenic acid mixture in radiotherapy induced dermatitis. In this study, we found Sanyrene significantly reduced the incidence rate of ≥ grade 2 RD when compared to control intervention. Moreover, patients in Sanyrene group had better Qol and more mild pain than those in control intervention group during the whole RT process up to 4 weeks after end of RT. As there is no consensus on the standard intervention, our study is an evidence to supplement the strategy of RD prophylaxis and management.Barrier films and dressings are kind of treatment methods for acute RD, but there is lack of consensus recommendation among guidelines for use of these methods. A single-blinded, randomized controlled study reported a silicone-based film dressing could reduce 41% and 49.4% risks of developing grade 2 and 3 skin toxicity compared to control arm in patients with head and neck cancer receiving radiotherapy, but skin related Qol was not improved by this dressing [Many studies reported linoleic acid and linolenic acid were benefit for skin by attenuating cutaneous inflammation through the competition with the inflammatory arachidonic acid and the inhibition of proinflammatory eicosanoid production [There were some limitations in this study. Firstly, it was difficult to blind physicians or patients in this trial because Sanyrene and control intervention (a cream containing Vitamin E and hyaluronic acid) had different properties. To reduce the confounding bias as much as possible, we chose two nurses who were not involved in the study to assess the grade of skin toxicity according to acute RTOG criteria. If consensus was not reached, the third nurse would assess the skin toxicity again and consensus meetings were conducted to resolve the disagreements. These nurses accepted training of toxicity assessing before beginning of the study. Therefore, we did blind the assessors of RD grade for trying to avoid bias. Secondly, subgroup analysis found Sanyrene effectively prevented incidence rate of ≥ grade 2 RD in patients with BC and HNC respectively, but bias was unavoidable due to small sample in each subgroup. Especially for head and neck cancer, concurrent chemoradiotherapy which could improve incidence of RD was not a rigorous inclusion criteria. Therefore, randomized controlled studies aiming to single disease should be conducted to confirm the efficacy of Sanyrene in preventing RD.