Clinical Trial Results:
Tacrolimus as Treatment of Breast Cancer-Related Lymphedema
Summary
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EudraCT number |
2020-000877-25 |
Trial protocol |
DK |
Global end of trial date |
03 Feb 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Dec 2022
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First version publication date |
18 Dec 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Tacrolimus2020
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04541290 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
J.B. Winsløwsvej 4, Odense C, Denmark, 5000
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Public contact |
Frederik C. Gulmark Hansen, Dept. of Plastic Surgery, Odense University Hospital, 0045 21734450, Jens.sorensen@rsyd.dk
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Scientific contact |
Jens Ahm Sørensen, Dept. of Plastic Surgery, Odense University Hospital, 0045 65412436, Jens.sorensen@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Dec 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Feb 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Feb 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the effect of Tacrolimus treatment on breast cancer-related lymphedema and how it influences quality of life in patients.
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Protection of trial subjects |
Prior to the injection of indocyanine green (ICG) into the subcutaneous tissue of the patients' hands, we injected local anesthesia so the participants would not feel the pain of the following injections and the possible itching sensation.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The patients were recruited through an internal waiting for participating in experimental lymphedema treatment trials. | ||||||||||||
Pre-assignment
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Screening details |
Initially, we screened the patients according to the following eligibility criteria: sex (female), age (30-65 years), breast cancer-related lymphedema, ISL stage I-II (yes), ipsilateral ALND (yes), bilateral breast cancer (no), allergy for tacrolimus or other macrolides (no), diagnosed immunodeficiency (no), psychiatric illness (no) and reduced kid | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
20 | ||||||||||||
Number of subjects completed |
20 | ||||||||||||
Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Treatment | ||||||||||||
Arm description |
This is a single arm trial with only the treatment group | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
protopic (0,1% tacrolimus)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The participants were given 13 tubes of Protopic (0.1 % tacrolimus) (Leo Pharma, Ballerup, Denmark) at baseline. They were instructed to apply the ointment in a thin layer covering the armpit, entire arm, and hand once daily for six months.
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Period 2
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Period 2 title |
3 months
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Treatment | ||||||||||||
Arm description |
This is a single arm trial with only the treatment group | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
protopic (0,1% tacrolimus)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The participants were given 13 tubes of Protopic (0.1 % tacrolimus) (Leo Pharma, Ballerup, Denmark) at baseline. They were instructed to apply the ointment in a thin layer covering the armpit, entire arm, and hand once daily for six months.
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Period 3
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Period 3 title |
6 months
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Treatment | ||||||||||||
Arm description |
This is a single arm trial with only the treatment group | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
protopic (0,1% tacrolimus)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The participants were given 13 tubes of Protopic (0.1 % tacrolimus) (Leo Pharma, Ballerup, Denmark) at baseline. They were instructed to apply the ointment in a thin layer covering the armpit, entire arm, and hand once daily for six months.
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Period 4
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Period 4 title |
12 months
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Treatment | ||||||||||||
Arm description |
This is a single arm trial with only the treatment group | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
protopic (0,1% tacrolimus)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The participants were given 13 tubes of Protopic (0.1 % tacrolimus) (Leo Pharma, Ballerup, Denmark) at baseline. They were instructed to apply the ointment in a thin layer covering the armpit, entire arm, and hand once daily for six months.
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
This is a single arm trial with only the treatment group | ||
Reporting group title |
Treatment
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Reporting group description |
This is a single arm trial with only the treatment group | ||
Reporting group title |
Treatment
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Reporting group description |
This is a single arm trial with only the treatment group | ||
Reporting group title |
Treatment
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Reporting group description |
This is a single arm trial with only the treatment group |
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End point title |
Lymphedema arm volume | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline, 3, 6 and 12 months
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Statistical analysis title |
Paired t test | ||||||||||||||||
Comparison groups |
Treatment v Treatment v Treatment
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
< 0.05 [1] | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Confidence interval |
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Notes [1] - Significant difference was seen from baseline to 6 months. Non significant changes were seen at 3 and 12 months |
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End point title |
Healthy arm volume | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline, 3, 6 and 12 months
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Statistical analysis title |
Paired t test | ||||||||||||||||
Comparison groups |
Treatment v Treatment v Treatment
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||||||
P-value |
> 0.05 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Confidence interval |
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Notes [2] - Paired t test was performed. There was no significant changes in healty arm volume in the group |
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End point title |
L-Dex Score | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, 3, 6 and 12 months
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No statistical analyses for this end point |
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End point title |
LYMPH ICF | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, 3, 6 and 12 months
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No statistical analyses for this end point |
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End point title |
DASH | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, 3, 6 and 12 months
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No statistical analyses for this end point |
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End point title |
SF-36 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, 3, 6, and 12 months
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No statistical analyses for this end point |
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End point title |
ICG-L | ||||||||||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline, 6 and 12 months
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
SEP 2020 - MAR 2022
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Assessment type |
Systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
none | ||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Treatment
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Reporting group description |
This is a single arm trial with only the treatment group | ||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Lack of control group |