Clinical Trial Results:
PreMENAC: Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia: A feasibility study (phase II)
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Summary
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EudraCT number |
2010-022897-14 |
Trial protocol |
NO GB DK |
Global end of trial date |
01 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Sep 2016
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First version publication date |
18 Sep 2016
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Other versions |
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Summary report(s) |
Results remenac summary |
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 |
PreMENAC-2011-01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01419145 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
NNorwegian University of Science and Technology (NTNU)
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Sponsor organisation address |
PB, Trondheim, Norway, 7491
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Public contact |
European Palliative Care Research Centre (PRC), European Palliative Care Research Centre (PRC),
Department of Cancer
Research and Molecular Me, prc@ntnu.no
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Scientific contact |
European Palliative Care Research Centre (PRC), European Palliative Care Research Centre (PRC),
Department of Cancer
Research and Molecular Me, prc@ntnu.no
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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 Sep 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Sep 2014
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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 overall objectives are the feasibility of patient recruitment, compliance to the multimodal intervention as well as the assessment of possible contamination of the control group. This will be assessed by:
• Patient recruitment
• Compliance to the intervention and attrition
• Compliance with the data collection procedures
• Contamination of the control group
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Protection of trial subjects |
There were no safety concerns identified. Eventual SAE and AEs were evaluated in the trial using CTCAE 3.0.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Oct 2011
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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 |
Norway: 23
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Country: Number of subjects enrolled |
United Kingdom: 23
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Worldwide total number of subjects |
46
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EEA total number of subjects |
46
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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) |
30
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From 65 to 84 years |
16
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
Screened for eligibility (n=399) | ||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
46 | ||||||||||||||||||
Number of subjects completed |
46 | ||||||||||||||||||
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Period 1
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental | ||||||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
M01A H01
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Investigational medicinal product code |
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Other name |
Celebra
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
300 mg celexocib daily for 6 weeks
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Arm title
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Control | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
- | ||
Reporting group title |
Control
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Reporting group description |
- | ||
Subject analysis set title |
Statistical analysis
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The primary endpoint was feasibility. This was assessed by recruitment and retention (number of patients screened and/or consented), compliance with the intervention (based on use of celecoxib, nutritional supplements, and exercise performed), and contamination of the control arm (number of patients who tried to mimic all or part of the intervention). Feasibility of recruitment and retention was assessed by proportion of patients screened versus those consented and attrition rates.
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End point title |
Feasibility | ||||||||||||
End point description |
The primary endpoint was feasibility. This was assessed by recruitment and retention (number of patients screened and/or consented), compliance with the intervention (based on use of celecoxib, nutritional supplements, and exercise performed), and contamination of the control arm (number of patients who tried to mimic all or part of the intervention). Feasibility of recruitment and retention was assessed by proportion of patients screened versus those consented and attrition rates. Compliance with the multimodal intervention was assessed according to individual components and thresholds of <50%, 50-80% and >80% were used. Compliance of >50% of the specific intervention in >50% of patients was considered acceptable.
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End point type |
Primary
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End point timeframe |
6 week
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| Notes [1] - Only assessed in the experimental arm |
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Statistical analysis title |
Feasibility | ||||||||||||
Comparison groups |
Experimental v Statistical analysis
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Number of subjects included in analysis |
46
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
October 3rd 2011 and until September 1st 2014.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
3.0
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Reporting groups
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Reporting group title |
Expermiental
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Reporting group description |
Reported grade 3 adverse event | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 | |||
