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Trial Title:
Topical Tacrolimus for Breast Cancer-related Lymphedema
NCT ID:
NCT06306274
Condition:
Lymphedema
Conditions: Official terms:
Lymphedema
Breast Cancer Lymphedema
Tacrolimus
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Tacrolimus
Description:
Tacrolimus (0,1%) ointment
Arm group label:
Active
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo ointment
Arm group label:
Placebo
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:
- How tacrolimus affects breast cancer related lymphedema regarding subjective and
objective measures (e.g. arm volume, lymphedema index, lymphatic function, and
quality of life).
- If maintenance treatment is effective. Participants will be treated with either
active drug or placebo once daily for six months followed by a six month maintenance
periode with treatment twice weekly. Assessments will be performed at baseline,
three, six, nine and 12 months.
Criteria for eligibility:
Criteria:
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
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Contact:
Last name:
Frederik Gulmark Hansen
Phone:
+4521734450
Email:
frederik.c.gulmark.hansen@rsyd.dk
Facility:
Name:
Zealand University Hospital
Address:
City:
Roskilde
Zip:
4000
Country:
Denmark
Contact:
Last name:
Michael Rose
Facility:
Name:
Lillebaelt Hospital
Address:
City:
Vejle
Zip:
4000
Country:
Denmark
Start date:
May 1, 2024
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Odense University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06306274
