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 |
The study will evaluate the feasibility of tacrolimus ointment in preventing lymphedema after breast cancer treatment. |
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E.2.2 | Secondary objectives of the trial |
arm volume, Quality of life for patients, lymph flow, bioimpediance. |
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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 |
Comparison in arm volume and quality of life to a seperate cohorts of patients from Vejle and Esbjerg (no treatment) |
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E.3 | Principal inclusion criteria |
• Kvinde • Diagnosticeret med brystkræft og skal have fjernet samtlige lymfeknuder i armhulen ved operation, som led i kræftbehandlingen. • Indikationen for fjernelse af alle lymfeknuder i armhulen. • Alder mellem 18-75 år • Postmopausal (udebleven menstruation i min. 12 mdr.) eller kontinuerligt brug af svangerskabsforebyggende midler (Spiral, p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion) • God almentilstand (ASA score 1 eller 2) • Modsatte arm er normal (intet lymfødem) • Forstår undersøgelsens formål og natur og giver skriftligt informeret samtykke. • Kan læse og forstå dansk.
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• Female • Diagnosed with breast cancer and must have removed all lymph nodes in the armpit during surgery as part of the cancer treatment. • The indication for removal of all lymph nodes in the armpit. • Age between 18-75 years • Postmopusal (unblocked period of 12 months) or continuous use of contraceptives (Spiral, birth control pills, implant, transdermal patch patch, vaginal ring or depot injection) • Good general condition (ASA score 1 or 2) • The opposite arm is normal (no lymphedema) • Understand the purpose and nature of the study and provide written informed consent. • Can read and understand Danish. |
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E.4 | Principal exclusion criteria |
• Pregnant, breastfeeding or wishing to conceive within the next year. • Bilateral breast cancer • Known allergy to Tacrolimus or the macrolide type antibiotics. • Removal of lymph nodes from the opposite armpit. • Known lymphedema in parallel or opposite arm • Other malignant disease in addition to breast cancer (non-melanoma skin cancer) • In medical treatment for diabetes mellitus. • Known with psychiatric disorder that may influence participation in the study. • Known with poor renal or hepatic function. |
• Gravid, ammende eller med ønske om at blive gravid indenfor det næste år. • Bilateral brystkræft • Kendt allergi overfor Tacrolimus eller antibiotika af makrolidtypen. • Fjernelse af lymfeknuder fra modsatte armhule. • Kendt lymfødem i samsidig eller modsatte arm • Anden malign sygdom udover brystkræft (fraset non-melanom hudcancer) • I medicinsk behandling for diabetes mellitus. • Kendt med psykiatrisk lidelse, der kan influere i deltagelsen i studiet. • Kendt med ringe nyre- eller leverfunktion. |
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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) |
Quality of life, lymph flow, bioimpediance |
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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 | Yes |
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 | 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 | Yes |
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 | 1 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |