Clinical trial • Phase II/III • Haematology

TACROLIMUS for Breast cancer-related lymphedema | Lymphedema

Phase II/III trial of TACROLIMUS for Breast cancer-related lymphedema | Lymphedema.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Breast cancer-related lymphedema | Lymphedema
Trial Stage
Phase II/III
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
10-03-2024
First CTIS Authorization Date
16-05-2024

Trial design

Randomised, placebo ointment (placebo): cutaneous ointment; max daily dose 1 g; max total dose 365 g; used as comparator (regimen not further specified). active investigational arm: tacrolimus ointment (tacrolimus): cutaneous ointment; max daily dose 3 g; max total dose 1200 g.-controlled Phase II/III trial across 3 sites in Denmark.

Randomised
Yes
Comparator
Placebo ointment (PLACEBO): cutaneous ointment; max daily dose 1 g; max total dose 365 g; used as comparator (regimen not further specified). Active investigational arm: Tacrolimus ointment (TACROLIMUS): cutaneous ointment; max daily dose 3 g; max total dose 1200 g.
Target Sample Size
80
Trial Duration For Participant
365

Eligibility

Recruits 80 No vulnerable population selected. Participants must be female adults (Age > 18 years) and comprehension of Danish required; informed consent to be provided by the participant; no assent procedures described..

Pregnancy Exclusion
Pregnant, breast-feeding, or aiming to conceive within the next year
Vulnerable Population
No vulnerable population selected. Participants must be female adults (Age > 18 years) and comprehension of Danish required; informed consent to be provided by the participant; no assent procedures described.

Inclusion criteria

  • {"criterion_text":"- Age > 18 years\n- BCRL ISL stage I or II\n- Pitting edema\n- Postmenopausal or use of Contraceptive drugs\n- Healthy opposite arm\n- L-Dex score>10\n- Lymphedema volume >10% of healthy arm\n- Comprehension of Danish\n- Female"}

Exclusion criteria

  • {"criterion_text":"- Pregnant, breast-feeding, or aiming to conceive within the next year\n- Bilateral breast cancer\n- Contralateral lymphadenectomy\n- Allergy to tacrolimus, macrolides, or iodine\n- Pacemaker implant\n- Known kidney or liver disease\n- Defect skin-barrier on the affected arm\n- Diagnosed immunodeficiency or treated with immunosuppressive medicine\n- No previous surgical treatment for lymphedema"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in lymphedema volume","definition_or_measurement_approach":"Primary endpoint assessed at the 12-month follow-up; defined as achieving a minimum of 10% reduction in lymphedema volume."}

Secondary endpoints

  • {"endpoint_text":"- Health-related quality of life","definition_or_measurement_approach":"Measured by health-related quality of life instruments (SF-36 document present)."}
  • {"endpoint_text":"- Lymphatic flow and - function","definition_or_measurement_approach":"Measurement approach not specified in available summary."}
  • {"endpoint_text":"- Skin fibrosis","definition_or_measurement_approach":"Measurement approach not specified in available summary."}
  • {"endpoint_text":"- Excessive water in the limb (L-Dex score)","definition_or_measurement_approach":"Measured using the L-Dex score."}

Recruitment

Planned Sample Size
80
Recruitment Window Months
45
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent form for adults available (L1_SIS_and_ICF_Adults). Participants must comprehend Danish. Consent provided by the participant; no assent procedures described.

Geography

Total Number Of Sites
3
Total Number Of Participants
80

Denmark

Earliest CTIS Part Ii Submission Date
10-05-2024
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
476
Number Of Sites
3
Number Of Participants
80

Sites

Site Name
Lillebaelt Hospital
Department Name
Department of Plastic Surgery
Principal Investigator Name
Tine Engberg Damsgaard
Principal Investigator Email
tine.m.engberg.damsgaard@rsyd.dk
Contact Person Name
Tine Engberg Damsgaard
Site Name
Odense University Hospital
Department Name
Department of Plastic Surgery
Principal Investigator Name
Frederik Gulmark Hansen
Principal Investigator Email
Frederik.C.Gulmark.Hansen@rsyd.dk
Contact Person Name
Frederik Gulmark Hansen
Site Name
Zealand University Hospital
Department Name
Department of Plastic and Breast Surgery
Principal Investigator Name
Michael Rose
Principal Investigator Email
mrose@regionsjaelland.dk
Contact Person Name
Michael Rose
Contact Person Email
mrose@regionsjaelland.dk

Sponsor

Primary sponsor

Full Name
Odense University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"1,10,5,6,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Glostrup Apotek","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TACROLIMUS
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
CUTANEOUS USE
Route
Cutaneous
Maximum Dose
3 g daily
Investigational Product Name
PLACEBO
Active Substance
PLACEBO
Modality
Other
Routes Of Administration
CUTANEOUS USE
Route
Cutaneous
Maximum Dose
1 g daily

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