LymphedemaPhase 1/2BCRL-TACRONCT04390685
Prevention of Breast Cancer-related Lymphedma With Tacrolimus
A Phase 1/2 study testing Tacrolimus ointment in people with Lymphedema, run by Odense University Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Tacrolimus ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesDenmark
- Study dates
- 26 Feb 2020to Sep 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Breast cancer with planned ALND
- postmenopausal or use of contraceptives
- good general health condition
- read and understand Danish
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Denmark3 sites
Sydvestjysk Sygehus
Esbjerg, 6700
Department of Plastic and Reconstructive Surgery
Odense, 5000
Sygehus Lillebælt Vejle
Vejle, 7100
About this study
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.
- Conditions
- Lymphedema
- Being tested
- Tacrolimus ointment
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ointmentDrug
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus ointment | Experimental | Apply whole arm, in a thin layer, once daily for one year Receives: Drug: Tacrolimus ointment |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema
Arm size change >= 10% using water displacement
Measured: 1 year
Secondary outcomes (5)
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Measured: 1 year
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Measured: 1 year
Subjective changes assessed using SF-36 questionnaire (Short form-36)
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered
Measured: 1 year
Change in L-DEX score using bioimpedance (Odense University Hospital Only).
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.
Measured: 1 year
Change in lymph drainage. (Odense University Hospital Only).
Change in lymph drainage assessed by indocyanine-green lymphangiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start26 Feb 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Gustaf Jørgensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390685
- Sponsor's protocol ID
- S-20180134
- Other IDs
- 2018-003416-50, 2018
- Acronym
- BCRL-TACRO
- Status last verified
- Jun 2021
- First submitted
- 7 May 2020
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Breast Cancer-related Lymphedma With Tacrolimus
- ClinicalTrials.gov ID
- NCT04390685
- Acronym / sponsor ID
- BCRL-TACRO / S-20180134
- Conditions
- Lymphedema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus ointment | Experimental | Drug: Tacrolimus ointmentApply whole arm, in a thin layer, once daily for one year |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Breast cancer with planned ALND
- postmenopausal or use of contraceptives
- good general health condition
- read and understand Danish
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus ointmentTreatment with tacrolimus ointment once daily for one year following axillary lymph node dissection | Drug | Tacrolimus ointment |
Primary outcome
Lymphedema
Time frame: 1 year
Arm size change >= 10% using water displacement
5 secondary outcomes
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Time frame: 1 year
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Time frame: 1 year
Subjective changes assessed using SF-36 questionnaire (Short form-36)
Time frame: 1 year
Change in L-DEX score using bioimpedance (Odense University Hospital Only).
Time frame: 1 year
Change in lymph drainage. (Odense University Hospital Only).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tacrolimus ointment in people with Lymphedema, run by Odense University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.