Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects

NCT02207608 | Completed Phase 2 Results

• 1 other identifier: EA-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate a possible role of intravesical Hyaluronic Acid in reducing local toxicity of Bacillus Calmette Guerin (BCG) used to treat bladder urothelial cell carcinoma.

Conditions

Poisoning by BCG Vaccine

Keywords

BCG; hyaluronic acid; non-muscle invasive bladder cancer; non bacterial cystitis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for Pain

  1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)

  Before and after six weeks of treatment (end of induction course)

Study Arms (2)

BCG alone (Immucist®)

ACTIVE COMPARATOR

Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone

Drug: BCG (Immucist®)

Hyaluronic acid

EXPERIMENTAL

Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).

Drug: Hyaluronic Acid; Drug: BCG (Immucist®)

Interventions

Hyaluronic Acid DRUG

Add hyaluronic acid to BCG Treatment

Also known as: Cystistat (Mylan, Pittsburgh, PA, U.S.A.)

Hyaluronic acid

BCG (Immucist®) DRUG

Usual BCG treatment

Also known as: BCG

BCG alone (Immucist®); Hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven non-muscle invasive bladder cancer;
• Indication to intravesical instillation of BCG according to EAU guidelines;
• Age \> 18 years;
• Willingness, to participate to the study;
• Written informed consent.

You may not qualify if:

• Previous or ongoing BCG or different intravesical instillations;
• Urinary tract infections (UTI) or other known pathologies of the lower urinary tract;
• Indication for a radical cystectomy;
• Severe systemic disorders, including neurological pathologies, kidney, liver or heart failure;
• Contraindications to BCG use.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Related Publications (1)

• Topazio L, Miano R, Maurelli V, Gaziev G, Gacci M, Iacovelli V, Finazzi-Agro E. Could hyaluronic acid (HA) reduce Bacillus Calmette-Guerin (BCG) local side effects? Results of a pilot study. BMC Urol. 2014 Aug 13;14:64. doi: 10.1186/1471-2490-14-64.

  PMID: 25123116 DERIVED

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Prof. Enrico Finazzi Agro
• Organization: University of Rome Tor Vergata

efinazzi@tin.it

+393296152920

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 28, 2015
• Results First Posted: May 28, 2015

Record last verified: 2015-05