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

Eur Rev Med Pharmacol Sci. 2012 May;16(5):639-45.

Abstract

Background: The purpose of this study was to evaluate the ability of rectal suppository 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 radiation delivering. An historical group was used as an external control. Acute rectal toxicity was scored weekly according to RTOG criteria. Time to occurrence 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 observed in rate of acute proctitis between the experimental arm and the control group: 32% in experimental arm versus 45% in control group (p = 0.08). A delay in the onset of acute rectal toxicity in patients treated with HA (p = 0.04) was showed.

Conclusions: Our findings suggested the role of HA in reducing acute proctitis in prostate cancer patients treated with radiotherapy. Further trials are needed to confirm these results.

MeSH terms

  • Acute Disease
  • Administration, Rectal
  • Aged
  • Case-Control Studies
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Hyaluronic Acid / adverse effects
  • Italy
  • Kaplan-Meier Estimate
  • Male
  • Medication Adherence
  • Multivariate Analysis
  • Proctitis / etiology
  • Proctitis / mortality
  • Proctitis / prevention & control*
  • Prospective Studies
  • Prostatic Neoplasms / mortality
  • Prostatic Neoplasms / radiotherapy*
  • Radiation Injuries / etiology
  • Radiation Injuries / mortality
  • Radiation Injuries / prevention & control*
  • Radiation-Protective Agents / administration & dosage*
  • Radiation-Protective Agents / adverse effects
  • Radiotherapy / adverse effects
  • Risk Assessment
  • Risk Factors
  • Suppositories
  • Time Factors
  • Treatment Outcome

Substances

  • Radiation-Protective Agents
  • Suppositories
  • Hyaluronic Acid