Topical Tacrolimus for Breast Cancer-related Lymphedema

Sponsor
Odense University Hospital
Study ID
NCT06306274
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tacrolimus — DRUG
    Tacrolimus (0,1%) ointment
  • Placebo — DRUG
    Placebo ointment

Study Details

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.

Key Dates

First listed
Mar 12, 2024
Start date
Sep 9, 2024
Status verified
Nov 2024
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
  • Placebo Comparator: Placebo

Primary Outcome Measure

Lymphedema volume [ Time Frame: Baseline to 12 months ]

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