Can we decrease the acute proctitis in prostate cancer patients using hyaluronic acid during radiation therapy: a prospective historically controlled clinical study

Background: The purpose of this study was to evaluate the ability of rectal sup- pository of hyaluronic acid to limit symptoms of acute radiation proctitis in patients with prostate cancer (PC). Materials and Methods: From January 2011 to October 2011, 50 consecutive patients, undergoing radiotherapy with radical or adjuvant intent for PC, were invited to use rectal suppository of hyaluronic acid (HA: Cicatridina ® suppository, Farma-Derma s.r.l., Sala Bolognese, BO, Italy) daily, before radia- tion delivering. An historical group was used as an external control. Acute rectal toxicity was scored weekly according to RTOG criteria. Time to occur- rence of acute rectal toxicity was taken as endpoint. Results: Compliance was good. Only 2% of HA treated patients had a G2 acute proctitis versus 7% of historical group, globally a difference was ob- served in rate of acute proctitis between the experi- mental arm and the control group: 32% in experi- mental arm versus 45% in control group (p = 0.08). A delay in the onset of acute rectal toxicity in pa- tients treated with HA (p = 0.04) was showed. Conclusions: Our findings suggested the role of HA in reducing acute proctitis in prostate can- cer patients treated with radiotherapy. Further trials are needed to confirm these results.