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A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01419145
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : June 16, 2017
Sponsor:
Collaborators:
University of Edinburgh
Oslo University Hospital
NHS Greater Glasgow and Clyde
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE August 16, 2011
First Posted Date  ICMJE August 17, 2011
Last Update Posted Date June 16, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Feasibility of recruitment and retention [ Time Frame: 12 weeks ]
The aim of this study is to investigate the feasibility of the multimodal intervention for cancer cachexia by assessing; enrolment rate, compliance with study intervention, contamination-rate in the control group with respect to any of the interventions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Official Title  ICMJE A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Brief Summary A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Cachexia
Intervention  ICMJE
  • Other: Multimodal intervention
    Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance.
  • Other: Standard care
    Standard cancer care
Study Arms  ICMJE
  • Experimental: Multimodal intervention
    Intervention: Other: Multimodal intervention
  • Active Comparator: Standard Care
    Intervention: Other: Standard care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2014)
46
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2011)
40
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main eligibility criteria:

  • Advanced non-small-cell lung cancer (stage III-IV) or pancreatic cancer not eligible for curative therapy
  • Due to commence chemo- or chemo radiotherapy
  • Karnofsky Performance Score ≥ 70
  • A life expectancy of ≥4 months and considered able to complete 2 months of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   United Kingdom
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT01419145
Other Study ID Numbers  ICMJE 2010/2620 (REK)
2010-022897-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Norwegian University of Science and Technology
Original Responsible Party Stein Kaasa, professor, MD, Norwegian University of Science and Technology
Current Study Sponsor  ICMJE Norwegian University of Science and Technology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Edinburgh
  • Oslo University Hospital
  • NHS Greater Glasgow and Clyde
  • Copenhagen University Hospital at Herlev
Investigators  ICMJE
Principal Investigator: Stein Kaasa, MD, PhD National Taiwan Normal University
Principal Investigator: Ken Fearon, MD, PhD University of Edinburgh
PRS Account Norwegian University of Science and Technology
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP