search
Back to results

Prevention of Breast Cancer-related Lymphedma With Tacrolimus (BCRL-TACRO)

Primary Purpose

Lymphedema

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Tacrolimus ointment
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphedema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Sydvestjysk Sygehus
  • Department of Plastic and Reconstructive Surgery
  • Sygehus Lillebælt Vejle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tacrolimus ointment

Control

Arm Description

Apply whole arm, in a thin layer, once daily for one year

Outcomes

Primary Outcome Measures

Lymphedema
Arm size change >= 10% using water displacement

Secondary Outcome Measures

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.
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
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
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.
Change in lymph drainage. (Odense University Hospital Only).
Change in lymph drainage assessed by indocyanine-green lymphangiography

Full Information

First Posted
May 7, 2020
Last Updated
June 24, 2021
Sponsor
Odense University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04390685
Brief Title
Prevention of Breast Cancer-related Lymphedma With Tacrolimus
Acronym
BCRL-TACRO
Official Title
Prevention of Breast Cancer-related Lymphedma With Tacrolimus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus ointment
Arm Type
Experimental
Arm Description
Apply whole arm, in a thin layer, once daily for one year
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Intervention Description
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
Primary Outcome Measure Information:
Title
Lymphedema
Description
Arm size change >= 10% using water displacement
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Description
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Time Frame
1 year
Title
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Description
Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Time Frame
1 year
Title
Subjective changes assessed using SF-36 questionnaire (Short form-36)
Description
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered
Time Frame
1 year
Title
Change in L-DEX score using bioimpedance (Odense University Hospital Only).
Description
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.
Time Frame
1 year
Title
Change in lymph drainage. (Odense University Hospital Only).
Description
Change in lymph drainage assessed by indocyanine-green lymphangiography
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Department of Plastic and Reconstructive Surgery
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sygehus Lillebælt Vejle
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 1 year after publication
IPD Sharing Access Criteria
Jens Ahm Sørensens review requests

Learn more about this trial

Prevention of Breast Cancer-related Lymphedma With Tacrolimus

We'll reach out to this number within 24 hrs