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

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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

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.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Other: Multimodal intervention Other: Standard care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study
Study Start Date : October 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419145


Locations
Norway
Oslo University Hospital Ullevål
Oslo, Norway
St Olavs Hospital
Trondheim, Norway
United Kingdom
University of Edinburgh
Edinburgh, United Kingdom
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

Additional Information:
Publications of Results:
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 ( EudraCT Number )
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Anti-Inflammatory Agents