E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Behandling av strålningsskadad urinblåsa med syrgas |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057480 |
E.1.2 | Term | Hyperbaric oxygen therapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable |
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E.2.2 | Secondary objectives of the trial |
•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 •To assess the severity of radiation injury having the RTOG-scale as variable •To assess health-related quality of life before and after HBO therapy having SF-36 as the variable
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 HBO therapy according to the local centres routines - Pregnancy - Mechanical ventilator support - Unable to follow and understand simple commands - Not oriented to person, place and time |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endoint is symptom rating after HBO therapy using the self-administrated EPIC-questionnaire original score as the primary variable |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline and at Visit 4, 6-8 weeks after finalized treatment |
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E.5.2 | Secondary end point(s) |
• Severity of radiation injury having the RTOG as the variable at baseline and visit 4 • Histological analysis of inflammation activity, degree of fibrosis, vascular density and the presence of stems cells at baseline and visit 4. • Health-related quality of life (SF36) at baseline visit 3, 4 and 5 • Post-study long-term follow-up follow up with Symptom rating (EPIC) and Health-related quality of life (SF36) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (visit 1) and 6-8 months (visit 4). SF-36 also immediately after finalized HBOT (visit 3 and 5) Long-term follow-up: 5 years after finalized study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Delayed start: The control group will start treatment 6-8 months after Group A |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last patient last visit (LVLS). A post-study 5 year follow-up will be made |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |