Updated protocol and guest participant results from the ACCeRT clinical study

Rogers, Elaine S. and Sasidharan, Rita and Sequeira, Graeme M. and Wood, Matthew R. and Bird, Stephen P. ORCID: https://orcid.org/0000-0002-5607-3829 and Keogh, Justin W.L. and Arroll, Bruce and Stewart, Joanna and MacLeod, Roderick D. (2020) Updated protocol and guest participant results from the ACCeRT clinical study. Journal of Basic Research in Medical Sciences, 7 (1). pp. 10-21. ISSN 2383-0506

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Abstract

Introduction
Cancer cachexia is a condition often seen at diagnosis, throughout chemotherapeutic treatments and in end stage Non-Small Cell Lung Cancer patients. These patients often experience a shorter life-expectancy and deterioration in performance status and reduced quality of life. New multi˗targeted regimens are required to be tested in this population to address these issues.

Materials and methods
The ACCeRT study is an open label, prospective, randomised controlled feasibility study investigating the use of eicosapentaenoic acid and COX-2 inhibitor (celecoxib) versus eicosapentaenoic acid, COX-2 inhibitor (celecoxib), progressive resistance training followed by ingestion of essential amino acids high in leucine in Non-Small Cell Lung Cancer cachectic patients. The study protocol was published in November 2011. Due to study participants and study team preferences a number of changes were made. Firstly, a change from a bolus drink containing 20 g of essential amino acids to an encapsulated form in divided doses over three days. Secondly, a change in leg strength analysis from utilising a leg/back dynamometry to a customised chair with a load cell testing extension isometric force. Thirdly, study drug dose reductions were now permitted. Fourthly, addition of two study sites which allowed participants to attend progressive resistance training sessions in their local area. Finally, a change in inclusion criteria to include participants that had received any first-line anti-cancer treatment. A guest participant was invited onto the study in April 2012, followed by the first study participant in June 2012.

Results
The guest participant showed trends in efficacy in a number of outcomes; stable fat free mass in the context of decreasing total body weight, with stable FAACT˗PWB, MFSI-SF physical, and WHOQOL-BREF QOL scores at week 20, all during documented disease progression now termed refractory cachexia. There were no treatment or exercise-related adverse events.

Conclusion
Publishing feasibility study protocols allows transparency in study interventions and assessments. The above ACCeRT regimen stabilised fat free mass and a number of physical/performance indicators and QOL in the guest participant.


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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Health and Wellbeing (1 Jan 2015 -)
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Health and Wellbeing (1 Jan 2015 -)
Date Deposited: 01 Sep 2020 06:23
Last Modified: 14 Sep 2020 01:08
Uncontrolled Keywords: Cancer cachexia, Resistance training, Amino acids
Fields of Research (2008): 11 Medical and Health Sciences > 1112 Oncology and Carcinogenesis > 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
11 Medical and Health Sciences > 1106 Human Movement and Sports Science > 110602 Exercise Physiology
Socio-Economic Objectives (2008): E Expanding Knowledge > 97 Expanding Knowledge > 970111 Expanding Knowledge in the Medical and Health Sciences
C Society > 92 Health > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920102 Cancer and Related Disorders
URI: http://eprints.usq.edu.au/id/eprint/39125

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