Cystitis, Radio Induced Clinical Trial
— RICH-ARTOfficial title:
Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
| Verified date | June 2019 |
| Source | Göteborg University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to assess the relief of symptoms after Hyperbaric
Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate
cancer Index Composite (EPIC)symptom estimation scale as primary variable.
Study hypothesis:
- HBOT can reduce or reverse the change or otherwise limit the damage of the bladder
function and/or structure, which arose as a result of radiation therapy of cancer in the
pelvic region organs.
- The effects of HBOT are associated with relief of symptoms that, at least in part, is
related to the reduction of the extent of the radiation damage.
- Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as
a sign of an improved function of the mucosa.
- Treatment results of HBOT remains, in whole or in part, during the follow-up (residual
effect)
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | August 9, 2018 |
| Est. primary completion date | August 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - Female or male aged 18-80 years - Intended curative radiation of the pelvic region as a treatment for cancer - End of radiation therapy more than 6 months ago - Radiation cystitis with Urological EPIC < 80 - Radiation cystitis is the most probable cause for the patient's symptoms Exclusion Criteria: - Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks) - Refractory incontinence requiring catheter or surgical intervention - Urine bladder capacity < 100ml - Fistula in the urine bladder - Contraindications for HBOT according to the local centres routines - Pregnancy - Mechanical ventilator support - Unable to follow and understand simple commands - Not oriented to person, place and time |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Rigshospitalet Copenhagen | Copenhagen | |
| Finland | Turku Hospital | Turku | |
| Norway | Haukeland Universitetssykehus | Bergen | |
| Sweden | Shalgrenska University Hospial | Gothenburg | |
| Sweden | Karolinska University Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Göteborg University | Sahlgrenska University Hospital, Sweden |
Denmark, Finland, Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | EPIC (Expanded Prostate cancer Index Composite) | EPIC was developed to measure health-related quality of life among men with prostate cancer (22) modified to enhance sensitivity to therapy effects. It comprises four summary domains; urinary, bowel, sexual and hormonal. The primary objective of this study is to assess the relief of symptoms after HBOT in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable, comparing results between group A (post treatment) and group B (pre treatment). All patients (Group A and B) will complete EPIC and SF-36 in a post-study long-term follow-up. This is done yearly for 5 years (18, 30, 42, 54 and 66 months post inclusion). |
At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description" | |
| Secondary | Microscopic assessment | To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable. Comparison will be made between group A (post treatment) and group B (pre treatment) | At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) | |
| Secondary | RTOG (Radiation Toxicity Grade by Radiation Therapy Oncology Group) | RTOG is an internationally well established research group in the oncology field. They have developed organ specific scales for quantification of both acute and late symptoms after radiation. The scale range is from 0 to 5, where 0 is used for normal function and findings and 5 for death directly related to injuries post radiation. Both subjective and objective findings are used when setting the score. Comparison will be made between Group A (post treatment) and Group B (pre treatment) |
At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) | |
| Secondary | SF-36 (Short Form Health Survey 36) | SF-36 is a self-administered questionnaire and contains 36 items which measure eight dimensions and assess health-related quality of life. Comparing results between Group A (post treatment) and Group B (pre treatment). All patients (Group A and B) will complete EPIC and SF-36 in a post-study long-term follow-up. This is done yearly for 5 years (18, 30, 42, 54 and 66 months post inclusion). |
At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description" | |
| Secondary | Adverse events | Adverse events (AE) are recorded during HBOT and Serious adverse events (SAE) until visit 4. | Every day during HBOT (8 weeks). |