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

This study is currently recruiting participants.
Verified November 2013 by Norwegian University of Science and Technology
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
ClinicalTrials.gov Identifier:
NCT01419145
First received: August 16, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.


Condition Intervention Phase
Cancer
Cachexia
Other: Multimodal intervention
Other: Standard care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Feasibility of recruitment and retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multimodal intervention 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.
Active Comparator: Standard Care Other: Standard care
Standard cancer care

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419145

Contacts
Contact: Stein Kaasa, MD, PhD stein.kaasa@ntnu.no
Contact: Ken Fearon, MD, PhD k.fearon@ed.ac.uk

Locations
Denmark
Herlev Hospital, Onkologisk Afdeling R Recruiting
Herlev, Denmark
Contact: Jonas Sørensen, MD       soerensen.jonas@gmail.com   
Contact: Anders Mellemgaard, MD, PhD       anders.mellemgaard@regionh.dk   
Principal Investigator: Jonas Sørensen, MD         
Norway
Oslo University Hospital Ullevål Recruiting
Oslo, Norway
Contact: Asta Bye, PhD       asta.bye@hioa.no   
Contact: Nina Aass, MD, PhD       nina.aass@ous-hf.no   
Principal Investigator: Nina Aass, MD, PhD         
Sub-Investigator: Asta Bye, PhD         
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Stein Kaasa, PhD MD       stein.kaasa@ntnu.no   
Contact: Trude R Balstad, MSc, PhD       trude.r.balstad@ntnu.no   
Sub-Investigator: Trude R Balstad, PhD         
Principal Investigator: Tora Skeidsvoll Solheim, MD         
United Kingdom
University of Edinburgh Recruiting
Edinburgh, United Kingdom
Contact: Ken Fearon, PhD MD       k.fearon@ed.ac.uk   
Contact: Barry Laird       barry.laird@ed.ac.uk   
Principal Investigator: Barry Laird, MD, PhD         
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Edinburgh
Oslo University Hospital
NHS Greater Glasgow and Clyde
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Stein Kaasa, MD, PhD NTNU
Principal Investigator: Ken Fearon, MD, PhD University of Edinburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01419145     History of Changes
Other Study ID Numbers: 2010/2620 (REK), 2010-022897-14
Study First Received: August 16, 2011
Last Updated: November 26, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Norwegian University of Science and Technology:
cachexia
neoplasms
complications
combined modality therapy
exercise therapy
diet therapy
anti-inflammatory agents

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014