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

O

Odense University Hospital

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Lymphedema

Treatments

Drug: Tacrolimus ointment

Study type

Interventional

Funder types

Other

Identifiers

NCT04390685
S-20180134
2018-003416-50 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Tacrolimus ointment
Experimental group
Description:
Apply whole arm, in a thin layer, once daily for one year
Treatment:
Drug: Tacrolimus ointment
Control
No Intervention group

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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