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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390685
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Mads Gustaf Jørgensen, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphedema Drug: Tacrolimus ointment Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Breast Cancer-related Lymphedma With Tacrolimus
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Tacrolimus ointment
Apply whole arm, in a thin layer, once daily for one year
Drug: Tacrolimus ointment
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection

No Intervention: Control



Primary Outcome Measures :
  1. Lymphedema [ Time Frame: 1 year ]
    Arm size change >= 10% using water displacement


Secondary Outcome Measures :
  1. Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire [ Time Frame: 1 year ]
    Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.

  2. Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire [ Time Frame: 1 year ]
    Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered

  3. Subjective changes assessed using SF-36 questionnaire (Short form-36) [ Time Frame: 1 year ]
    Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered

  4. Change in L-DEX score using bioimpedance (Odense University Hospital Only). [ Time Frame: 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.

  5. Change in lymph drainage. (Odense University Hospital Only). [ Time Frame: 1 year ]
    Change in lymph drainage assessed by indocyanine-green lymphangiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390685


Contacts
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Contact: Mads G Jørgensen, MD 29210114 ext +45 Mads.Gustaf.Jorgensen@rsyd.dk
Contact: Jens A Sørensen, MD, PhD

Locations
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Denmark
Sydvestjysk Sygehus Recruiting
Esbjerg, Denmark, 6700
Contact: Lena F Carstensen, MD         
Contact: Mette Tambour, PT         
Department of Plastic and Reconstructive Surgery Recruiting
Odense, Denmark, 5000
Contact: Mads G Jørgensen, MD       Mads.Gustaf.Jorgensen@rsyd.dk   
Contact: Jens A Sørensen, MD, PhD         
Sygehus Lillebælt Vejle Recruiting
Vejle, Denmark, 7100
Contact: Christina Kjær, MD         
Contact: Kim G Ingwersen, PT         
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Mads Gustaf Jørgensen, Medical doctor, ph.d.-student., Odense University Hospital
ClinicalTrials.gov Identifier: NCT04390685    
Other Study ID Numbers: S-20180134
2018-003416-50 ( EudraCT Number )
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Analytic Code
Time Frame: Starting 1 year after publication
Access Criteria: Jens Ahm Sørensens review requests

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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
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action