Tacrolimus as Treatment of Breast Cancer-Related Lymphedema
Condition: Breast Cancer Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      BACKGROUND Breast cancer-related lymphedema is a severe and life-long side-effect to breast
      cancer treatment. The condition increases the risk of infections and decreases health-related
      quality of life (HR-QOL) in patients. No prophylactic or curative treatment is currently
      available for this condition.

      CD4+-cells plays a critical role in the development of lymphedema. The cells facilitate
      inflammation and fibrosis formation in the subcutaneous tissue which inhibits lymphatic
      regeneration. Tacrolimus is an immunosuppressive and anti-inflammatory macrolide that targets
      the CD4+-cells. Tacrolimus as treatment of lymphedema has already shown promising results in
      animal studies. Tacrolimus has the potential to cure an otherwise uncurable and life-long
      side-effect of BC and will therefore benefit a large number of patients who suffers from
      BCRL.

      AIM To assess the effect of Tacrolimus treatment on breast cancer-related lymphedema METHOD
      Study design A pilot study with a planned inclusion of 20 patients with a 12 month follow-up
      period. The purpose of this study is to assess the effect of tacrolimus treatment on
      lymphedema and HR-QOL. Results are attained from objective measures and questionnaires.

      The patients will be seen at a consultation prior to the treatment start and then 3 times
      hereafter (at 3, 6 and 12 months) as follow up consultations where effect of treatment is
      evaluated.

      Primary endpoint:

      - Arm volume measured with water displacement test.

      Secondary endpoints:

        -  Arm volume measured with measuring tape and calculated with volume of a cone formula

        -  Patient-reported outcome measured through the Danish versions of , LYMPH-ICF, DASH and
           SF-36 questionnaires

        -  Bioimpedance

        -  Lymphangiography Primary- and secondary endpoint data will be collected at each of the 3
           consultations (prior to treatment and 3 and 6 months after the treatment start).

      CLINICAL IMPACT This will be the first clinical pharmacological study on regarding treatment
      of lymphedema with Tacrolimus. This study will test the feasibility and efficacy of
      Tacrolimus ointment in a population of breast cancer patients who have developed lymphedema.
      The study may lead to a routine clinical implementation of tacrolimus ointment to patients
      diagnosed with Lymphedema. Regardless of the outcome, the study will benefit the patients and
      future research in the field of lymphedema.
    


Intervention name(s): Protopic 0.1 % Topical Ointment
Intervention type(s): Drug
Intervention description(s): Applied in a thin layer covering all of the arm including the armpit and hand once a day for six months
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment