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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list