E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
breast cancer patients
lymphedema |
borstkanker
lymfoedeem |
|
E.1.1.1 | Medical condition in easily understood language |
presence of swelling of the arm after breast cancer treatment |
zwelling van de arm na borstkanker behandeling |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
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 | 10025233 |
E.1.2 | Term | Lymphedema |
E.1.2 | System Organ Class | 100000013375 |
|
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 main objective entails detecting early development of lymphedema
and establishing a decrease in the incidence of lymphedema and/or
improvement or stabilization of the lymphofluoroscopic image when
treatment is started early. |
|
E.2.2 | Secondary objectives of the trial |
Establishing pre-existing factors in the development of lymphedema
after breast cancer treatment. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age >18y (since the investigation using ICG is not dangerous for
pregnant women, women with child bearing age are included)
- Women/ men with breast cancer and scheduled for unilateral axillary
lymph node dissection (ALND) or sentinel node biopsy (SNB)
- Oral and written approval of informed consent
- Understands Dutch |
|
E.4 | Principal exclusion criteria |
- Age <18y
- Oedema of the upper limb from other causes
- Cannot participate during the entire study period
- Mentally or physically unable to participate in the study
- Contra-indication for the use of ICG: allergy to iodine,
hyperthyroidism
- Metastatic disease |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Incidence of lymphoedema of arm and hand (defined as 5% volume
increase compared to the contralateral side)
- Change of lymphatic architecture and function |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Change of extracellular fluid in the arm
- Change of water content of the arm
- Change of quality of life
- Number of episodes of erysipelas
- Number of adverse events to the garment |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
the IMP is only used for diagnosis, in each patient, at different times |
IMP wordt gebruikt als diagnose middel bij iedere patient en wordt dus
niet gerandomiseerd |
|
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
the IMP is only used for diagnostic purpose in every patient, 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 |
the IMP will be used in every patient, randomisation is done for |
|
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 | 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 3 years after inclusion, suspected by nov 2021 |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |