title: Could hyaluronic acid (HA) reduce Bacillus Calmette-Guérin (BCG) local side effects? Results of a pilot study.
abstract: BACKGROUND
  Bacillus Calmette-Guérin (BCG) is considered the most effective treatment to reduce recurrence and progression of non-muscle invasive bladder cancer (NMIBC) but can induce local side effects leading to treatment discontinuation or interruption. Aim of this exploratory study is to investigate if the sequential administration of Hyaluronic acid (HA) may reduce local side effects of BCG.
  
  
  METHODS
  30 consecutive subjects undergoing BCG intravesical administration for high risk NMIBC were randomized to receive BCG only (Group A) or BCG and HA (Group B). A 1 to 10 Visual Analog Scale (VAS) for bladder pain, International Prostate Symptom Score (IPSS) and number of micturitions per day were evaluated in the two groups before and after six weekly BCG instillations. Patients were also evaluated at 3 and 6 months by means of cystostopy and urine cytology.
  
  
  RESULTS
  One out of 30 (3,3%) patients in group A dropped out from the protocol, for local side effects. Mean VAS for pain was significantly lower in group B after BCG treatment (4.2 vs. 5.8, p = 0.04). Post vs. pre treatment differences in VAS for pain, IPSS and number of daily micturitions were all significantly lower in group B. Three patients in group A and 4 in group B presented with recurrent pathology at 6 month follow up.
  
  
  CONCLUSIONS
  These preliminary data suggest a possible role of HA in reducing BCG local side effects and could be used to design larger randomized controlled trials, assessing safety and efficacy of sequential BCG and HA administration.
  
  
  BACKGROUND
  NCT02207608 (ClinicalTrials.gov) 01/08/2014. Policlinico Tor Vergata Ethics Committee, resolution n 69-2011.
authors.forename: Luca
authors.initials: L
authors.lastname: Topazio
authors.forename: Roberto
authors.initials: R
authors.lastname: Miano
authors.forename: Valentina
authors.initials: V
authors.lastname: Maurelli
authors.forename: Gabriele
authors.initials: G
authors.lastname: Gaziev
authors.forename: Mauro
authors.initials: M
authors.lastname: Gacci
authors.forename: Valerio
authors.initials: V
authors.lastname: Iacovelli
authors.affiliation: Department of Experimental Medicine and Surgery, Tor Vergata University, Rome, Italy. efinazzi@tin.it.
authors.forename: Enrico
authors.initials: E
authors.lastname: Finazzi-Agrò
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects* / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced / Q000517:prevention & control; D010865:Pilot Projects; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D014555:Urination Disorders / Q000139:chemically induced / Q000517:prevention & control
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D006820:Hyaluronic Acid