Clinical Trial Results:
Effectiveness of Botulinum Toxin Infiltration for treatment of upper limb dysfunctions after treatment for breast cancer
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Summary
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EudraCT number |
2014-005114-33 |
Trial protocol |
BE |
Global end of trial date |
01 Jan 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2020
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First version publication date |
09 Feb 2020
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Other versions |
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Summary report(s) |
Manuscript Botox_UL outcomes Manuscript botox_pain outcomes |
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 |
s57283
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UZ/KULeuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Nele Devoogdt, UZ Leuven, +32 16342171, an.degroef@faber.kuleuven.Be
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Scientific contact |
Nele Devoogdt, UZ Leuven, +32 16342171, an.degroef@faber.kuleuven.Be
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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 Jan 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jan 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jan 2020
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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 |
The aim of this study is to examine the effect of Botolinum Toxine infiltration in the pectoral muscle, in combination with an individual physical therapy programme, on pain and upper limb dysfunctions in women after breast cancer
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Protection of trial subjects |
All participants gave written informed consent before data collection began.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Feb 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Belgium: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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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) |
41
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were recruited at the Multidisciplinary Breast Center and the Department of Physical Medicine and Rehabilitation of the University Hospitals in Leuven between February 2015 and July 2016. | |||||||||
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Pre-assignment
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Screening details |
All referred patients (n=103) were screened, and 50 (47%) agreed to participate. The 53 nonparticipants had more pN1 and less pN2-3 tumors (P=.028) and had less radiotherapy (P=.016) compared with participants. Fifty patients were included in the study and were randomly assigned to an intervention group (n=25) and a control group (n=25). | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention group | |||||||||
Arm description |
Patients in the intervention group received an intramuscular injection of BTX-A (100 units, Botox) in the pectoralis major muscle. Within the first week after the BTX-A or saline infiltration, all participants started an individual standard physical therapy program of 12 weeks (1 session per week) at the University Hospital Leuven. The sessions were individual and lasted 30 minutes. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Botulinum Toxin A
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Infiltration
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Dosage and administration details |
Patients in the intervention group received an intramuscular injection
of BTX-A (100 units, Botox) in the pectoralis major
muscle.
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Arm title
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Control group | |||||||||
Arm description |
Patients in the control group received a placebo infiltration consisting of 50mL of saline (Mini-Plasco 20mL NaCl 0.9%).Within the first week after the BTX-A or saline infiltration, all participants started an individual standard physical therapy program of 12 weeks (1 session per week) at the University Hospital Leuven. The sessions were individual and lasted 30 minutes. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Mini-Plasco 20mL NaCl 0.9%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Infiltration
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Dosage and administration details |
Patients in the control group received a placebo infiltration
consisting of 50mL of saline (Mini-Plasco 20mL NaCl 0.9%).
Injections were evenly spread over the muscle belly, including the
clavicular and sternal part.
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Baseline characteristics reporting groups
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Reporting group title |
Intervention group
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Reporting group description |
Patients in the intervention group received an intramuscular injection of BTX-A (100 units, Botox) in the pectoralis major muscle. Within the first week after the BTX-A or saline infiltration, all participants started an individual standard physical therapy program of 12 weeks (1 session per week) at the University Hospital Leuven. The sessions were individual and lasted 30 minutes. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control group
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Reporting group description |
Patients in the control group received a placebo infiltration consisting of 50mL of saline (Mini-Plasco 20mL NaCl 0.9%).Within the first week after the BTX-A or saline infiltration, all participants started an individual standard physical therapy program of 12 weeks (1 session per week) at the University Hospital Leuven. The sessions were individual and lasted 30 minutes. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention group
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Reporting group description |
Patients in the intervention group received an intramuscular injection of BTX-A (100 units, Botox) in the pectoralis major muscle. Within the first week after the BTX-A or saline infiltration, all participants started an individual standard physical therapy program of 12 weeks (1 session per week) at the University Hospital Leuven. The sessions were individual and lasted 30 minutes. | ||
Reporting group title |
Control group
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Reporting group description |
Patients in the control group received a placebo infiltration consisting of 50mL of saline (Mini-Plasco 20mL NaCl 0.9%).Within the first week after the BTX-A or saline infiltration, all participants started an individual standard physical therapy program of 12 weeks (1 session per week) at the University Hospital Leuven. The sessions were individual and lasted 30 minutes. | ||
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End point title |
change in pain intensity at the upper limb region 3 months after baseline | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
change in pain intensity at the upper limb
region 3 months after baseline
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Statistical analysis title |
multivariate linear model for repeated measurement | |||||||||
Statistical analysis description |
Multivariate linear model for repeated (longitudinal) measurements, using an unstructured covariance matrix. The primary analysis was change in pain intensity at the upper limb region 3 months after baseline.
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Comparison groups |
Intervention group v Control group
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Number of subjects included in analysis |
50
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
3
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
-13 | |||||||||
upper limit |
19 | |||||||||
Variability estimate |
Standard deviation
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Adverse events information [1]
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Timeframe for reporting adverse events |
baseline until 6 months follow-up
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | ||
Dictionary version |
3
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious events happened during the trial. |
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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. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/29409922 |
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