E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Late radiation toxicity |
Late radiatieschade |
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E.1.1.1 | Medical condition in easily understood language |
Late radiation toxicity |
Late bestralingsschade |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
To compare self-reported breast/chest wall pain between breast cancer patients with late radiation toxicity treated with HBOT compared to controls receiving no HBO treatment |
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E.2.2 | Secondary objectives of the trial |
• To compare QoL in breast cancer patients with late radiation toxicity treated with HBOT with breast cancer patients with late radiation toxicity receiving no HBO treatment; • To compare the effect of HBOT versus usual care (e.g. physiotherapy, analgetics, edema) on late radiation toxicity effects (i.e. arm mobility, (breast) edema, fibrosis, arm pain and cosmetic outcome) in breast cancer patients; • To measure the effect of HBOT on skin oxygenation in breast cancer patients with late radiation toxicity; • To evaluate the side effects of HBOT in breast cancer patients with late radiation toxicity
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire - Participation >12 months in the UMBRELLA cohort; - Previous treatment with radiotherapy for breast cancer; - Finished surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.
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E.4 | Principal exclusion criteria |
- Poor responder (i.e. return of ≤2 UMBRELLA questionnaires); - Previous HBOT; - Contra-indications for HBOT (e.g. (severe) COPD/asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure); - Current metastatic disease or recurrent breast cancer. Additional exclusion criteria based on screening visit - Inability to follow schedule of all consecutive HBO treatments (e.g. due to scheduled holidays > 2 days); - Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).
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E.5 End points |
E.5.1 | Primary end point(s) |
Main study endpoint is breast/chest wall pain, measured on late radiation toxicity questionnaire 7 or 8 depending on previous surgery (resp. mastectomy or breast conserving therapy or breast reconstruction). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Prior to HBOT, 3 months after HBOT |
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E.5.2 | Secondary end point(s) |
Secondary study endpoints are: 1. Quality of life (QoL) measured by EORTC-QLQ C30 and EORTC-QLQ BR23; 2. Patient reported late radiation toxicity, assessed by late radiation toxicity questionnaire (ability to move the arm, (breast) edema, fibrosis); 3. Physician reported late radiation toxicity, assessed by CTCAE version 4.03*; 4. Cosmetic outcome; both patient reported with BREAST-Q, reported by medical photograph* and with physical examination using the Patient and Observer Scar Assessment Scale (POSAS) score v2.0*; 5. Side effects of treatment with HBO*; 6. Oxygenation of the skin prior to and after HBOT*; 7. Patient reported experience measure on HBOT*. * Only in HBOT group |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time points per secondary endpoint specified: 1. Prior to HBOT and 3 months after HBOT. 2. Prior to HBOT (screening) and 3 months after HBOT. 3. Prior to HBOT, after HBOT and 3 months after HBOT. 4. Patient reported: Prior to HBOT and 3 months after HBOT. Physician reported: prior to HBOT, after HBOT and 3 months after HBOT. 5. During HBOT, after HBOT 6. Prior to HBOT and after HBOT. 7. 3 months after HBOT
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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 | 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 | 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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |