Tacrolimus as Treatment of Breast Cancer-Related Lymphedema
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.