EUCTR2018-003416-50-DK
Active, not recruiting
Phase 1
Prevention of breast cancer-related lymphedema with tacrolimus
ConditionsymphedemaMedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsProtopic 0.1%
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ymphedema
- Sponsor
- Odense University Hospital
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
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.
Outcomes
Primary Outcomes
Not specified
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