E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Dermatitis as a result of radiation therapy for breast cancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061103 |
E.1.2 | Term | Dermatitis radiation |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063562 |
E.1.2 | Term | Radiation skin injury |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
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 evaluate if melatonin can protect against radiation injury in women receiving radiation therapy as part of their treatment of breast cancer. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate if melatonin can reduce the useage of steroid cream in the treatment of radiaiton dermatitis. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosed with early breast cancer Over 49 years old Have had radical tumor resection surgery Follows treatment regimens and follow-up at Rigshospitalet Written informed consent after written and verbal information |
|
E.4 | Principal exclusion criteria |
Inability to understand Danish, written or spoken Mental illness* Previous therapy with ionizing radiation in the thoracic or neck area Use of bolus for radiation therapy**
* Defined as having a diagnosis and being in medical treatment, or if anticipated poor compliance. ** A bolus is a material which has dose absorption properties equivalent to tissue. It is placed on the irradiated area to alter dosing or target of the radiation therapy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
RTOG's acute radiation morbidity scoring criteria of the skin Image analysis of clinical photographs after radiation exposure EORTC's QLQ-BR23, specifically the breast symptoms |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
RTOG's acute radiation morbidity scoring criteria of the skin: Two weeks after last radiation fraction Image analysis of clinical photographs after radiation exposure: Two weeks after last radiation fraction EORTC's QLQ-BR23, specifically the breast symptoms: Last day of radiation therapy |
|
E.5.2 | Secondary end point(s) |
RTOG's acute radiation morbidity scoring criteria of the skin Image analysis of clinical photographs after radiation exposure EORTC's QLQ-BR23 Useage of steroid cream throughout the trial |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Once weekly during the radiation treatment, and once weekly for 3 weeks following the last radiation fraction |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 4 |
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 | 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
|
Last visit of last subject. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |