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

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

Completed

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Key information

Conditions

Cancer Body Weight Body Weight Changes Cachexia Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital Ullevål, Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal intervention

Other

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.

Standard care

Other

Standard cancer care

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

Copenhagen University Hospital at Herlev
NHS Greater Glasgow and Clyde
Oslo University Hospital
University of Edinburgh

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Aug 17, 2011
Registry last updated: Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed