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 |
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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 | 100000004866 |
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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 |
To assess the effect of Tacrolimus treatment on breast cancer-related lymphedema and how it influences quality of life in patients. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female • Lymphedema diagnosis as a result of BC treatment • Significant pitting edema • Grade I-II lymphedema • Age between 30-65 years • Postmenopausal (absence/lack of menstruation in at least 12 consecutive months) or continuously usage of contraceptive drugs (Spiral, birth-control pills, implant, transdermal patches, vaginal ring or depot injection). Contraceptive drugs must be used throughout the project and at least three weeks subsequent to the ending of the project (last application of the ointment) • Clinically good general condition • No lymphedema in the opposite arm (Normal arm) • Understands the purpose of the study and gives written consent to participate • Can read and understand the Danish language
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• Kvinde • Lymfødem-diagnose som konsekvens af behandling for brystkræft • Udtalt pitting-ødem • Grad I-II lymfødem • Alder mellem 30-65 år • Postmenopausal (fravær af menstruation i mindst 12 på hinanden efterfølgende måneder) eller kontinuerligt brug af prævention (Spiral, p-piller, implantater, transdermale plastre, vaginal ring eller depotinjektion). Præventionen skal anvendes gennem hele projektet og mindst 3 uger efter sidste behandling (sidste påsmøring af salven) • Klinisk god almentilstand • Intet lymfødem i den modsatte arm (normal arm) • Forstår formålet med studiet og skriftligt giver sit informerede samtykke • Kan læse og forstå det danske sprog
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E.4 | Principal exclusion criteria |
• Pregnant, breast-feeding or with wish of pregnancy within the next year. • Bilateral BC • Grade 0, III or IV lymphedema • Known allergies for Tacrolimus or any other macrolide. • Removal of lymph nodes in the opposite armpit • Suffers from psychiatric disorders that may affect the participation in the project • Reduced kidney or liver function • Defect skin-barrier • Diagnosed immunodeficiency
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• Gravid, ammende eller med ønske om graviditet inden for det næste år • Har haft brystkræft i begge bryster • Grad 0, III eller IV lymfødem • Kendte allergier for Tacrolimus eller andre stoffer af makrolid-typen • Fjernelse af lymfeknuder i modsatte armhule • Lider af psykisk sygdom, som kan influere deltagelsen i projektet • Nedsat nyre- eller leverfunktion • Defekt hudbarriere • Diagnosticeret med immundefekt
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Bioimpedance Lympgangiography Patient-reported outcome measures (questionnaires)
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Bioimpedance Lymfangiografi Patient-reported-outcome measures (spørgeskemaer) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |