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Topical Tacrolimus for Breast Cancer-related Lymphedema

NCT06306274 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Lymphedema

Interventions

DRUG

Tacrolimus

Tacrolimus (0,1%) ointment

DRUG

Placebo

Placebo ointment

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306274 on ClinicalTrials.gov