Condition category
Urological and Genital Diseases
Date applied
05/03/2013
Date assigned
20/03/2013
Last edited
30/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Radiation cystitis is a complication of radiation therapy administered to pelvic tumors. Late radiation cystitis can develop months to years after radiation therapy, and presents principally as hematuria (presence of blood in urine), which ranges from mild to life-threatening. The aim of this study is assess the tolerability, safety and effectiveness of a hyaluronic acid and chondroitin sulphate combination in patients with late radiation tissue cystitis.

Who can participate?
Patients with late radiation tissue cystitis after receiving radiotherapy for pelvic tumors

What does the study involve?
Participants are treated with a hyaluronic acid and chondroitin sulphate combination that is delivered as a liquid drug directly into the bladder through a tube (intravesical instillation). Participants with severe haematuria (daily) receive instillations 5 days/week in the 1st month, 3 days/week in the 2nd month, 2 days/week in the 3rd month, once weekly in months 4-6, every two weeks in months 7-8, every three weeks in months 9-10, and monthly/bimonthly for one year. Participants without or with occasional haematuria receive instillations 3 days/week in the 1st month, 2 days/week in the 2nd month, 1 day/week in months 3-4, every two weeks in months 5-6, every three weeks in months 7-8, and monthly/bimonthly for one year. The tolerability, safety and effectiveness of the treatment and changes in quality of life are measured at 3 and 12 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Vita-Salute San Raffaele University (Italy)

When is the study starting and how long is it expected to run for?
May 2010 to December 2013

Who is funding the study?
Regional Health System (Italy)

Who is the main contact?
Dr Massimo Lazzeri

Trial website

Contact information

Type

Scientific

Primary contact

Dr Massimo Lazzeri

ORCID ID

Contact details

Department of Urology
San Raffaele Turro
Vita-Salute San Raffaele University
Via Stamira d’Ancona 20
Milan
20127
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001/Magenta

Study information

Scientific title

Intravesical hyaluronic acid (HA) and chondroitin sulphate (CS) for treatment of signs and symptoms of patients with late radiation tissue cystitis (LRTC): an investigative pilot study

Acronym

Study hypothesis

To test the hypothesis that a combined solution containing high concentration of HA and CS may improve LRTC symptoms and signs.

Ethics approval

Institutional Review Board (001/Magenta)

Study design

Prospective longitudinal non-randomized investigative pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Late radiation tissue cystitis with or without haematuria

Intervention

Enrolled patients were treated with intravesical instillations of Ialuril®, a 50 ml/vial solution containing HA 800 mg and CS 1 mg. Patients with severe haematuria (daily) received instillations 5 days/week in the 1st month, 3 days/week in the 2nd month, 2 days/week in the 3rd month, once weekly in months 4-6, every two weeks in months 7-8, every three weeks in months 9-10, and monthly/bimonthly for one year.

Patients without or with occasional haematuria received instillations 3 days/week in the 1st month, 2 days/week in the 2nd month, 1 day/week in months 3-4, every two weeks in months 5-6, every three weeks in months 7-8, and monthly/bimonthly for one year. The solution was retained in the bladder for 45-60 minutes in the 1st month, with rotation in four positions (supine, prone, left and right flank), and for ≥ 80 minutes thereafter.

Intervention type

Drug

Phase

Not Applicable

Drug names

Hyaluronic acid, chondroitin sulphate

Primary outcome measures

The tolerability, safety and efficacy of the treatment at reducing the symptoms and signs of LRTC at 3 and 12 months

Secondary outcome measures

Quality of Life (QoL), measured at 3 and 12 months

Overall trial start date

01/05/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible patients with symptomatic LRTC after receiving primary or adjuvant radiotherapy for pelvic neoplasms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients (male and female, age range: 40-80 years) undergoing chemotherapy
2. Those with a life expectancy of less than 24 months
3. Those with radiological confirmed metastasis
4. Patients receiving radiotherapy for bladder cancer
5. Patients with documented urethral strictures

Recruitment start date

01/05/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Italy

Trial participating centre

Vita-Salute San Raffaele University
Milan
20127
Italy

Sponsor information

Organisation

Institut Biochimique SA (IBSA) (Italy)

Sponsor details

Via Emilia
Lodi
26900
Italy

Sponsor type

Industry

Website

http://www.ibsa-international.com/

Funders

Funder type

Government

Funder name

Regional Health System (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/06/2017: Plain English summary added.