Prevention of Breast Cancer-related Lymphedma With Tacrolimus
BCRL-TACRO
2 other identifiers
interventional
60
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2020
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2020
CompletedFirst Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJune 25, 2021
June 1, 2021
2.5 years
May 7, 2020
June 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Lymphedema
Arm size change \>= 10% using water displacement
1 year
Secondary Outcomes (5)
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
1 year
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
1 year
Subjective changes assessed using SF-36 questionnaire (Short form-36)
1 year
Change in L-DEX score using bioimpedance (Odense University Hospital Only).
1 year
Change in lymph drainage. (Odense University Hospital Only).
1 year
Study Arms (2)
Tacrolimus ointment
EXPERIMENTALApply whole arm, in a thin layer, once daily for one year
Control
NO INTERVENTIONInterventions
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
Eligibility Criteria
You may qualify if:
- Female
- Breast cancer with planned ALND
- postmenopausal or use of contraceptives
- good general health condition
- read and understand Danish
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sydvestjysk Sygehus
Esbjerg, 6700, Denmark
Department of Plastic and Reconstructive Surgery
Odense, 5000, Denmark
Sygehus Lillebælt Vejle
Vejle, 7100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor, ph.d.-student.
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 15, 2020
Study Start
February 26, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
June 25, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR, ANALYTIC CODE
- Time Frame
- Starting 1 year after publication
- Access Criteria
- Jens Ahm Sørensens review requests
all IPD that underlie results in a publication