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

This study is ongoing, but not recruiting participants.
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: August 21, 2014
Last verified: August 2014
  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: May 2015
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: August 21, 2014
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
Body Weight
Body Weight Changes
Emaciation
Signs and Symptoms
Weight Loss
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014