Email updates

Keep up to date with the latest news and content from BMC Cancer and BioMed Central.

Open Access Study protocol

A randomised feasibility study of EPA and Cox-2 inhibitor (Celebrex) versus EPA, Cox-2 inhibitor (Celebrex), Resistance Training followed by ingestion of essential amino acids high in leucine in NSCLC cachectic patients - ACCeRT Study

Elaine S Rogers12*, Roderick D MacLeod13, Joanna Stewart4, Stephen P Bird5 and Justin WL Keogh67

Author Affiliations

1 University of Auckland, Department of General Practice and Primary Health Care, Auckland, New Zealand

2 Auckland City Hospital, Department of Oncology, Auckland, New Zealand

3 North Shore Hospice, Takapuna, Auckland, New Zealand

4 University of Auckland, Department of Epidemiology and Biostatistics, Auckland, New Zealand

5 Charles Sturt University, School of Human Movement Studies, Bathurst, Australia

6 Bond University, Faculty of Health Sciences and Medicine, Gold Coast. Australia

7 AUT University, Centre for Physical Activity and Nutrition Research, Auckland, New Zealand

For all author emails, please log on.

BMC Cancer 2011, 11:493  doi:10.1186/1471-2407-11-493

Published: 23 November 2011

Abstract

Background

Cancer cachexia is a syndrome of progressive weight loss. Non-small cell lung cancer patients experience a high incidence of cachexia of 61%. Research into methods to combat cancer cachexia in various tumour sites has recently progressed to the combination of agents.

The combination of the anti-cachectic agent Eicosapentaenoic acid (EPA) and the cyclo-oxygenase-2 (COX-2) inhibitor celecoxib has been tested in a small study with some benefit. The use of progressive resistance training (PRT) followed by the oral ingestion of essential amino acids (EAA), have shown to be anabolic on skeletal muscle and acceptable in older adults and other cancer groups.

The aim of this feasibility study is to evaluate whether a multi-targeted approach encompassing a resistance training and nutritional supplementation element is acceptable for lung cancer patients experiencing cancer cachexia.

Methods/Design

Auckland's Cancer Cachexia evaluating Resistance Training (ACCeRT) is an open label, prospective, randomised controlled feasibility study with two parallel arms. All patients will be treated with EPA and the COX-2 inhibitor celecoxib on an outpatient basis at the study site. In the experimental group patients will participate in PRT twice a week, followed by the ingestion of essential amino acids high in leucine. A total of 21 patients are planned to be enrolled. Patients will be randomised using 1:2 ratio with 7 patients enrolled into the control arm, and 14 patients into the treatment arm. The primary endpoint is the acceptability of the above multi-targeted approach, determined by an acceptability questionnaire.

Discussion

To our knowledge ACCeRT offers for the first time the opportunity to investigate the effect of stimulating the anabolic skeletal muscle pathway with the use of PRT along with EAA alongside the combination of EPA and celecoxib in this population.

Trial registration

Netherlands Trial Register (NTR): ACTRN12611000870954