Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04390685

Acronym

BCRL-TACRO

Enrollment

Registered

2020-05-15

Start date

2020-02-26

Completion date

2022-09-30

Last updated

2021-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Brief summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Tacrolimus ointment may prevent lymphedema by inhibition of CD4+T cells.

Interventions

DRUGTacrolimus ointment

Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Female * Breast cancer with planned ALND * postmenopausal or use of contraceptives * good general health condition * read and understand Danish

Exclusion criteria

* Pregnant, breastfeeding it wishing to conceive with the next year * bilateral breast cancer * known allergy to tacrolimus or macrolides * known lymphedema * other malignant disease apart from keratinocyte cancer * in medical treatment for diabetes mellitus * known psychiatric condition which may influence participation * known renal or hepatic function

Design outcomes

Primary

Measure	Time frame	Description
Lymphedema	1 year	Arm size change \>= 10% using water displacement

Secondary

Measure	Time frame	Description
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire	1 year	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire	1 year	Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Subjective changes assessed using SF-36 questionnaire (Short form-36)	1 year	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered
Change in L-DEX score using bioimpedance (Odense University Hospital Only).	1 year	Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.
Change in lymph drainage. (Odense University Hospital Only).	1 year	Change in lymph drainage assessed by indocyanine-green lymphangiography

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026