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
| ISRCTN | ISRCTN37534393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37534393 |
| Secondary identifying numbers | 001/Magenta |
- Submission date
- 05/03/2013
- Registration date
- 20/03/2013
- Last edited
- 30/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Urology
San Raffaele Turro
Vita-Salute San Raffaele University
Via Stamira dAncona 20
Milan
20127
Italy
Study information
| Study design | Prospective longitudinal non-randomized investigative pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | To test the hypothesis that a combined solution containing high concentration of HA and CS may improve LRTC symptoms and signs. |
| Ethics approval(s) | Institutional Review Board (001/Magenta) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2010 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Eligible patients with symptomatic LRTC after receiving primary or adjuvant radiotherapy for pelvic neoplasms |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Italy
Study participating centre
20127
Italy
Sponsor information
Industry
Via Emilia
Lodi
26900
Italy
| Website | http://www.ibsa-international.com/ |
|---|---|
"ROR" |
https://ror.org/02cf8gj49 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
30/06/2017: Plain English summary added.
