Topical Tacrolimus for Breast Cancer-related Lymphedema

Phase 2
Conditions
Interventions
Registration Number
NCT06306274
Lead Sponsor
Odense University Hospital
Brief Summary

The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:
...

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
Female
Target Recruitment
80
Inclusion Criteria
  • Age over 18 years
  • BCRL ISL stage I or II
  • Pitting edema
  • Postmenopausal or use of Contraceptive drugs
  • Healthy opposite arm
  • L-Dex score over 10
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Exclusion Criteria
  • Pregnant, breast-feeding, or aiming to conceive within the next year
  • Bilateral breast cancer
  • Contralateral lymphadenectomy
  • Allergy to tacrolimus, macrolides, or iodine
  • Pacemaker
  • Known kidney or liver disease
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ActiveTacrolimus-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Lymphedema volumeBaseline to 12 months

Change in lymphedema volume (volume of lymphedema arm - volume of healty arm)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Odense University Hospital

🇩🇰

Odense, Denmark

Zealand University Hospital

🇩🇰

Roskilde, Denmark

Lillebaelt Hospital

🇩🇰

Vejle, Denmark

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