Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Lymphedema Clinical Trial

— BCRL-TACRO  

Official title:

Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04390685
• Other study ID #: S-20180134
• Secondary ID: 2018-003416-50
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 26, 2020
• Est. completion date: September 2022

Study information

• Verified date: June 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Drug:
• Tacrolimus ointment
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection

Locations

Country	Name	City	State
Denmark	Sydvestjysk Sygehus	Esbjerg
Denmark	Department of Plastic and Reconstructive Surgery	Odense
Denmark	Sygehus Lillebælt Vejle	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphedema	Arm size change >= 10% using water displacement	1 year
Secondary	Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.	1 year
Secondary	Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire	Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered	1 year
Secondary	Subjective changes assessed using SF-36 questionnaire (Short form-36)	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered	1 year
Secondary	Change in L-DEX score using bioimpedance (Odense University Hospital Only).	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.	1 year
Secondary	Change in lymph drainage. (Odense University Hospital Only).	Change in lymph drainage assessed by indocyanine-green lymphangiography	1 year