Tacrolimus as Treatment of Breast Cancer-Related Lymphedema
NCT ID: NCT04541290
Last Updated: 2022-02-09
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2020-09-22
2022-01-06
Brief Summary
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CD4+-cells plays a critical role in the development of lymphedema. The cells facilitate inflammation and fibrosis formation in the subcutaneous tissue which inhibits lymphatic regeneration. Tacrolimus is an immunosuppressive and anti-inflammatory macrolide that targets the CD4+-cells. Tacrolimus as treatment of lymphedema has already shown promising results in animal studies. Tacrolimus has the potential to cure an otherwise uncurable and life-long side-effect of BC and will therefore benefit a large number of patients who suffers from BCRL.
AIM To assess the effect of Tacrolimus treatment on breast cancer-related lymphedema METHOD Study design A pilot study with a planned inclusion of 20 patients with a 12 month follow-up period. The purpose of this study is to assess the effect of tacrolimus treatment on lymphedema and HR-QOL. Results are attained from objective measures and questionnaires.
The patients will be seen at a consultation prior to the treatment start and then 3 times hereafter (at 3, 6 and 12 months) as follow up consultations where effect of treatment is evaluated.
Primary endpoint:
\- Arm volume measured with water displacement test.
Secondary endpoints:
* Arm volume measured with measuring tape and calculated with volume of a cone formula
* Patient-reported outcome measured through the Danish versions of , LYMPH-ICF, DASH and SF-36 questionnaires
* Bioimpedance
* Lymphangiography Primary- and secondary endpoint data will be collected at each of the 3 consultations (prior to treatment and 3 and 6 months after the treatment start).
CLINICAL IMPACT This will be the first clinical pharmacological study on regarding treatment of lymphedema with Tacrolimus. This study will test the feasibility and efficacy of Tacrolimus ointment in a population of breast cancer patients who have developed lymphedema. The study may lead to a routine clinical implementation of tacrolimus ointment to patients diagnosed with Lymphedema. Regardless of the outcome, the study will benefit the patients and future research in the field of lymphedema.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Women with stage 1-2 lymphedema due to breast cancer treatment
Protopic 0.1 % Topical Ointment
Applied in a thin layer covering all of the arm including the armpit and hand once a day for six months
Interventions
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Protopic 0.1 % Topical Ointment
Applied in a thin layer covering all of the arm including the armpit and hand once a day for six months
Eligibility Criteria
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Inclusion Criteria
* Female
* Lymphedema diagnosis as a result of breast cancer treatment
* Active Lymphedema (excessive fluid)
* Significant lymphedema
* Grade I-II lymphedema
* Postmenopausal (Absence/lack of menstruation in at least 12 consecutive months) or continuously usage of contraceptive drugs (Spiral, birth-control pills, implant, transdermal patches, vaginal ring or depot injection). Contraceptive drugs must be used throughout the project and at least three weeks subsequent to the ending of the project (last application of the ointment).
* Clinically good general condition No lymphedema in the opposite arm (normal arm)
* Understands the purpose og the study and gives written consent to participate
* Can read and understand the danish language
Exclusion Criteria
* Bilateral breast cancer
* Grade 0, III or IV lymphedema
* Known allergies for Tacrolimus or and other macrolide
* Removal of lymph nodes in the opposite armpit
* Suffers from psychiatric disorders that may affect the participation in the project
* Reduced kidney or liver function
* Defect skin-barrier
* Diagnosed immunodeficiency
30 Years
65 Years
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Mads Gustaf Jørgensen
Doctor of Medicine, Principal investigator
Principal Investigators
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Jens A Sørensen, MD Prof. PhD
Role: STUDY_CHAIR
Department of Plastic Surgery at Odense University Hospital
Locations
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Department of Plastic Surgery, Odense University Hospital
Odense, , Denmark
Countries
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References
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Zou L, Liu FH, Shen PP, Hu Y, Liu XQ, Xu YY, Pen QL, Wang B, Zhu YQ, Tian Y. The incidence and risk factors of related lymphedema for breast cancer survivors post-operation: a 2-year follow-up prospective cohort study. Breast Cancer. 2018 May;25(3):309-314. doi: 10.1007/s12282-018-0830-3. Epub 2018 Feb 3.
Ribeiro Pereira ACP, Koifman RJ, Bergmann A. Incidence and risk factors of lymphedema after breast cancer treatment: 10 years of follow-up. Breast. 2017 Dec;36:67-73. doi: 10.1016/j.breast.2017.09.006. Epub 2017 Oct 6.
Grada AA, Phillips TJ. Lymphedema: Pathophysiology and clinical manifestations. J Am Acad Dermatol. 2017 Dec;77(6):1009-1020. doi: 10.1016/j.jaad.2017.03.022.
Taghian NR, Miller CL, Jammallo LS, O'Toole J, Skolny MN. Lymphedema following breast cancer treatment and impact on quality of life: a review. Crit Rev Oncol Hematol. 2014 Dec;92(3):227-34. doi: 10.1016/j.critrevonc.2014.06.004. Epub 2014 Jul 2.
Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5.
Terada M, Yoshimura A, Sawaki M, Hattori M, Naomi G, Kotani H, Adachi Y, Iwase M, Kataoka A, Sugino K, Mori M, Horisawa N, Ozaki Y, Iwata H. Patient-reported outcomes and objective assessments with arm measurement and bioimpedance analysis for lymphedema among breast cancer survivors. Breast Cancer Res Treat. 2020 Jan;179(1):91-100. doi: 10.1007/s10549-019-05443-1. Epub 2019 Sep 18.
Sackey H, Johansson H, Sandelin K, Liljegren G, MacLean G, Frisell J, Brandberg Y. Self-perceived, but not objective lymphoedema is associated with decreased long-term health-related quality of life after breast cancer surgery. Eur J Surg Oncol. 2015 Apr;41(4):577-84. doi: 10.1016/j.ejso.2014.12.006. Epub 2015 Jan 13.
Ghanta S, Cuzzone DA, Torrisi JS, Albano NJ, Joseph WJ, Savetsky IL, Gardenier JC, Chang D, Zampell JC, Mehrara BJ. Regulation of inflammation and fibrosis by macrophages in lymphedema. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1065-77. doi: 10.1152/ajpheart.00598.2014. Epub 2015 Feb 27.
Ogata F, Fujiu K, Matsumoto S, Nakayama Y, Shibata M, Oike Y, Koshima I, Watabe T, Nagai R, Manabe I. Excess Lymphangiogenesis Cooperatively Induced by Macrophages and CD4(+) T Cells Drives the Pathogenesis of Lymphedema. J Invest Dermatol. 2016 Mar;136(3):706-714. doi: 10.1016/j.jid.2015.12.001. Epub 2015 Dec 10.
Muller GG, Jose NK, de Castro RS, de Holanda EC. Long-term use of topical tacrolimus ointment: a safe and effective option for the treatment of vernal keratoconjunctivitis. Arq Bras Oftalmol. 2019 Mar-Apr;82(2):119-123. doi: 10.5935/0004-2749.20190026. Epub 2019 Jan 24.
Remitz A, Harper J, Rustin M, Goldschmidt WF, Palatsi R, van der Valk PG, Sharpe G, Smith CH, Dobozy A, Turjanmaa K; European Tacrolimus Ointment Study Group. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children. Acta Derm Venereol. 2007;87(1):54-61. doi: 10.2340/00015555-0167.
Gardenier JC, Kataru RP, Hespe GE, Savetsky IL, Torrisi JS, Nores GD, Jowhar DK, Nitti MD, Schofield RC, Carlow DC, Mehrara BJ. Topical tacrolimus for the treatment of secondary lymphedema. Nat Commun. 2017 Feb 10;8:14345. doi: 10.1038/ncomms14345.
Harvey LA. REDCap: web-based software for all types of data storage and collection. Spinal Cord. 2018 Jul;56(7):625. doi: 10.1038/s41393-018-0169-9. No abstract available.
Lasinski BB, McKillip Thrift K, Squire D, Austin MK, Smith KM, Wanchai A, Green JM, Stewart BR, Cormier JN, Armer JM. A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM R. 2012 Aug;4(8):580-601. doi: 10.1016/j.pmrj.2012.05.003.
Damstra RJ, Glazenburg EJ, Hop WC. Validation of the inverse water volumetry method: A new gold standard for arm volume measurements. Breast Cancer Res Treat. 2006 Oct;99(3):267-73. doi: 10.1007/s10549-006-9213-0. Epub 2006 Jun 3.
Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
Klassen AF, Dominici L, Fuzesi S, Cano SJ, Atisha D, Locklear T, Gregorowitsch ML, Tsangaris E, Morrow M, King T, Pusic AL. Development and Validation of the BREAST-Q Breast-Conserving Therapy Module. Ann Surg Oncol. 2020 Jul;27(7):2238-2247. doi: 10.1245/s10434-019-08195-w. Epub 2020 Jan 21.
Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9.
Gulmark Hansen FC, Jorgensen MG, Sorensen JA. Treatment of Breast Cancer-Related Lymphedema With Topical Tacrolimus: A Prospective, Open-Label, Single-Arm, Phase II Pilot Trial. J Breast Cancer. 2023 Feb;26(1):46-59. doi: 10.4048/jbc.2023.26.e2. Epub 2023 Jan 19.
Related Links
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NORDICAN. Association of the Nordic Cancer Registries. Danish Cancer Society. Available from http://www.ancr.nu, accessed on 24 February 2020. Cancer \[Internet\]. 2011;1-2.
Tacrolimus Topical: MedlinePlus Drug Information \[Internet\]. \[cited 2020 Feb 24\].
Other Identifiers
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Tacrolimus_2020
Identifier Type: -
Identifier Source: org_study_id
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