Lymphedema MedDRA version: 20.0 Level: LLT Classification code 10025233 Term: Lymphedema System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Protopic 0.1%
Product Name: tacrolimus
Pharmaceutical Form: Ointment
INN or Proposed INN: tacrolimus
CAS Number: 104987-11-3
Other descriptive name: TACROLIMUS MONOHYDRATE
Concentration un
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will evaluate the feasibility of tacrolimus ointment in preventing lymphedema after breast cancer treatment.;Secondary Objective: arm volume, Quality of life for patients, lymph flow, bioimpediance.;Primary end point(s): Feasibility;Timepoint(s) of evaluation of this end point: 12 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life, lymph flow, bioimpediance;Timepoint(s) of evaluation of this end point: 12 months follow up | — |
Countries
Denmark
Contacts
Public ContactDept. of Plastic Surgery
Odense University Hospital
Outcome results
None listed