Acceptability, compliance, and safety of non-small cell lung cancer cachectic participants continuing compassionate access in 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. (2021) Acceptability, compliance, and safety of non-small cell lung cancer cachectic participants continuing compassionate access in the ACCeRT clinical study. Journal of Health Science and Medical Research. ISSN 2586-9981

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Abstract

Objective: Cancer cachexia is defined as: a ‘multifactorial syndrome’, and it has been suggested that a multitargeted approach is required in its management. High prevalence is seen within non-small cell lung cancer, and patients may continue to experience cachexia post end of anti-cancer treatment, and in the late/end stage.

Material and Methods: Participants who had completed week 20/End of Trial visit in the main Auckland’s Cancer Cachexia evaluating Resistance Training (ACCeRT) study were invited to continue with treatment under compassionate use. Participants could continue with 2.09 g of eicosapentaenoic acid (EPA), 300 mg COX-2 inhibitor (celecoxib), once daily; plus two sessions per week of progressive resistance training (PRT), and 20 g oral essential amino acids (EAA); high in leucine, in a split dose over three days post each session. Data was collected on the acceptability, compliance and adherence to medication/PRT sessions. Secondary endpoints included: change in body weight and fat free mass, handgrip and leg strength, the Functional Assessment of Anorexia/Cachexia Therapy, Multidimensional Fatigue Symptom Inventory-Short Form, World Health Organization Quality of Life — BREF, Glasgow prognostic score, and pro-inflammatory cytokines.

Results: All six participants, who completed the main ACCeRT study, opted to continue with compassionate use. Acceptability remained high, with overall compliance to last study/PRT visit of 81.0% for EPA, 98.8% for celecoxib, 78.9% for PRT and 77.2% for EAA. Participants continued to lose body weight and Fat-Free Mass, along with reduced albumin and increased C-Reactive protein levels. Mean time on compassionate study treatment was 78 days, and with a mean overall survival of 257 days (140 + 117).

Conclusion: Non-small cell lung cancer (NSCLC) cachectic patients are willing to be enrolled onto a multi-targeted treatment regimen, and may benefit from cachexia symptom management even during their late/refractory stage.


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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: Published online: October 2021. This is an open access article under the CC BY-NC-ND license (http://www.jhsmr.org/index.php/jhsmr/about/editorialPolicies#openAccessPolicy).
Faculty/School / Institute/Centre: No Faculty
Faculty/School / Institute/Centre: No Faculty
Date Deposited: 07 Oct 2021 05:28
Last Modified: 08 Nov 2021 23:11
Uncontrolled Keywords: refractory cancer cachexia; resistance training; NSCLC cachectic patients; multi-targeted treatment
Fields of Research (2008): 11 Medical and Health Sciences > 1112 Oncology and Carcinogenesis > 111204 Cancer Therapy (excl. Chemotherapy and Radiation Therapy)
Fields of Research (2020): 42 HEALTH SCIENCES > 4201 Allied health and rehabilitation science > 420199 Allied health and rehabilitation science not elsewhere classified
42 HEALTH SCIENCES > 4208 Traditional, complementary and integrative medicine > 420899 Traditional, complementary and integrative medicine not elsewhere classified
Socio-Economic Objectives (2008): E Expanding Knowledge > 97 Expanding Knowledge > 970111 Expanding Knowledge in the Medical and Health Sciences
Socio-Economic Objectives (2020): 28 EXPANDING KNOWLEDGE > 2801 Expanding knowledge > 280112 Expanding knowledge in the health sciences
Identification Number or DOI: doi:10.31584/jhsmr.2021840
URI: http://eprints.usq.edu.au/id/eprint/43753

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