Prevention of breast cancer-related lymphedema with tacrolimus

Phase 1

• Conditions: ymphedema; MedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003416-50-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

•Kvinde
•Diagnosticeret med brystkræft og skal have fjernet samtlige lymfeknuder i armhulen ved operation, som led i kræftbehandlingen.
•Indikationen for fjernelse af alle lymfeknuder i armhulen.
•Alder mellem 18-75 år
•Postmopausal (udebleven menstruation i min. 12 mdr.) eller kontinuerligt brug af svangerskabsforebyggende midler (Spiral, p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion)
•God almentilstand (ASA score 1 eller 2)
•Modsatte arm er normal (intet lymfødem)
•Forstår undersøgelsens formål og natur og giver skriftligt informeret samtykke.
•Kan læse og forstå dansk.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Pregnant, breastfeeding or wishing to conceive within the next year.
• Bilateral breast cancer
• Known allergy to Tacrolimus or the macrolide type antibiotics.
• Removal of lymph nodes from the opposite armpit.
• Known lymphedema in parallel or opposite arm
• Other malignant disease in addition to breast cancer (non-melanoma skin cancer)
• In medical treatment for diabetes mellitus.
• Known with psychiatric disorder that may influence participation in the study.
• Known with poor renal or hepatic function.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study will evaluate the feasibility of tacrolimus ointment in preventing lymphedema after breast cancer treatment.;Secondary Objective: arm volume, Quality of life for patients, lymph flow, bioimpediance.;Primary end point(s): Feasibility;Timepoint(s) of evaluation of this end point: 12 months follow up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life, lymph flow, bioimpediance;Timepoint(s) of evaluation of this end point: 12 months follow up