E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic radiation-induced gastrointestinal symptoms |
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E.1.1.1 | Medical condition in easily understood language |
Long-term adverse effects of radiotherapy for pelvic cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 goal is to test the clinical benefits of high pressure oxygen therapy in restoring normal bowel function to patients suffering chronic radiation-induced gastrointestinal complications following curative radiotherapy for pelvic cancers. |
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E.2.2 | Secondary objectives of the trial |
A secondary aim is to collect rectal tissue for future investigations into cell and molecular mechanisms underlying therapeutic response. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Trans-HOT. Mechanisms of normal tissue healing in response to hyperbaric oxygen therapy in patients with chronic complications of pelvic radiotherapy. Under preperation for ethical review and approval. |
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E.3 | Principal inclusion criteria |
i) Age over 18 years. ii) Past history of a malignant pelvic neoplasm (T1-4 N0-2 M0), including carcinoma of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus, vagina, vulva and ovary. iii) A minimum 12 months follow-up post-radiotherapy (36 months for patients with past history of stage T4 and/or N2 disease). iv) No evidence of cancer recurrence. v) Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any LENT SOMA category, or grade 1 with difficult intermittent symptoms. vi) Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period. vii) Physical and psychological fitness for HBO therapy. viii) Written informed consent and availability for follow up.
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E.4 | Principal exclusion criteria |
i) Surgery for rectal cancer. ii) Prior hyperbaric oxygen therapy (excluding treatment for decompression illness). iii) Prior treatment with even a single dose of bleomycin. iv) Claustrophobia. v) Epilepsy. vi) Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax. vii) Previous middle/inner ear operations (except grommets and similar procedures) &/or irremediable inability to equalise middle ear pressure. viii) Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints i) Overall gastrointestinal symptoms score using the modified Inflammatory Bowel Disease Questionnaire (IBDQ), using a 3% p-value. ii) Change in rectal IBDQ bleeding score between the two groups, using a 2% p-value.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline; 2 weeks post treatment; 3*, 6*, 9* and 12 months post treatment
* patient self-assessment questionnaires only
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E.5.2 | Secondary end point(s) |
Secondary clinical endpoints i) Physician assessment of bowel dysfunction using LENT SOMA scales of radiation injury. ii)Patient self-assessments using EORTC QLQ-C30 and Defaecation Problem Subscale of QLQ-CR38. iii) Photographic images of rectal mucosa taken via flexible sigmoidoscopy.) iv)Physician assessment of rectal dysfunction based on the modified CTCAE grading.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline; 2 weeks post treatment; 3*, 6*, 9* and 12 months post treatment
* patient self-assessment questionnaires only |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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The study end date is deemed to be the date of last data capture.
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |