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

Cancer research study

What is the primary objective of this 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cancer

Cachexia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Multimodal interventionNutritional 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 careStandard cancer care

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Multimodal intervention

Standard Care

Study Status

Completed

Start Date: October 2011

Completed Date: November 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Feasibility of recruitment and retention

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Stein Kaasa, MD, PhD

Lead Sponsor: Norwegian University of Science and Technology

Collaborator: University of Edinburgh

More information:https://clinicaltrials.gov/show/NCT01419145

Solheim TS, Laird BJA, Balstad TR, Stene GB, Bye A, Johns N, Pettersen CH, Fallon M, Fayers P, Fearon K, Kaasa S. A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):778-788. doi: 10.1002/jcsm.12201. Epub 2017 Jun 14.

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