AL study- traditional Chinese medicine combination Astragalus membranaceus and Ligustrum lucidum in people with advanced malignancy: research protocol for an open labelled pilot study

Authors

  • Bhagwant K. Sekhon Faculty of Pharmacy and Centre for Education and Research on Ageing, University of Sydney and Concord Hospital, Sydney, NSW
  • Philip Beale Concord Cancer Centre, Concord Hospital Sydney, University of Sydney, Sydney, NSW
  • Janette L. Vardy Sydney Medical School, Concord Hospital Sydney, University of Sydney, Sydney, NSW
  • Kellie A. Charles Discipline of Pharmacology, Sydney Medical School, University of Sydney, Sydney, NSW
  • Ross D. Brown Haematology, Sydney Cancer Centre, Royal Prince Alfred Hospital Sydney Medical School, Sydney, NSW
  • Henry Liang Chinese Medicine Program, School of Science and Health, University of Western Sydney, Sydney
  • Stephen J. Clarke Director Area Cancer Services (Northern Sydney Cancer Centre), Kolling Institute of Medical Research and the Bill Walsh Cancer Research Laboratory, Royal North Shore Hospital and University of Sydney, Sydney, NSW
  • Andrew J. McLachlan Faculty of Pharmacy and Centre for Education and Research on Ageing, University of Sydney and Concord Hospital, Sydney, NSW

DOI:

https://doi.org/10.18203/2349-3259.ijct20173614

Keywords:

Advanced cancer, Traditional Chinese medicine, Astragalus, Ligustrum, Pilot study

Abstract

Background: AL is a traditional Chinese medicine (TCM) combination commonly used as an adaptogen to improve energy levels, immunity and quality of life in those suffering from chronic diseases such as cancer. While the combination Astragalus membranaceus and Ligustrum lucidum (AL) has been investigated in China as an adjunct to standard anticancer therapies in numerous clinical studies of variable quality reported in the Chinese literature, independent assessment of its effects on safety, tolerability and efficacy are lacking. Our objectives are to determine the safety and tolerability of AL and investigate its effects on inflammation, quality of life and immunity in people with advanced malignancy in the Australian healthcare setting.

Methods: The AL study is a prospectively registered, open labelled pilot multi-centre study investigating AL in people with advanced malignancy. Inclusion criteria include participants with recurrent or metastatic cancer who are not undergoing chemotherapy or palliative chemotherapy. All participants (n=25) will receive 6 capsules of AL twice daily (equivalent to 25g raw herb) for 12 weeks. Follow up consultations will monitor safety, tolerability, quality of life, immune function and adverse events. Participants will be assessed at baseline and at weeks 3, 6, 9 and 12. The primary outcome will determine the effect of AL on safety and tolerability. Secondary outcomes will include inflammation, quality of life, immune function, disease status and survival. Appropriate statistical analysis will be conducted on the pilot study data. Potential associations will be investigated where relevant.

Conclusions: This study will firstly establish the safety and tolerability of this TCM combination ‘AL’ in people with advanced malignancy in the Australian healthcare system and provide important information regarding its effect on markers that may affect survival as well as explore changes in quality of life and immune function. The impact of this research may allow the design of future studies integrating AL with standard therapy for people with advanced malignancy.

Author Biographies

Bhagwant K. Sekhon, Faculty of Pharmacy and Centre for Education and Research on Ageing, University of Sydney and Concord Hospital, Sydney, NSW

PhD, Research officer, Faculty of Pharmacy,

Philip Beale, Concord Cancer Centre, Concord Hospital Sydney, University of Sydney, Sydney, NSW

Associate Professor 

Clinical Director of Cancer Services for the Sydney Local Health District (incorporating Royal Prince Alfred, Concord and Canterbury Hospitals)

 

Janette L. Vardy, Sydney Medical School, Concord Hospital Sydney, University of Sydney, Sydney, NSW

Professor 
Principal Research Fellow
Medicine, Concord Clinical School

Kellie A. Charles, Discipline of Pharmacology, Sydney Medical School, University of Sydney, Sydney, NSW

Associate Professor

Ross D. Brown, Haematology, Sydney Cancer Centre, Royal Prince Alfred Hospital Sydney Medical School, Sydney, NSW

PhD, Haematologist, Hospital Scientist

Henry Liang, Chinese Medicine Program, School of Science and Health, University of Western Sydney, Sydney

PhD, Lecturer and the Uniclinic coordinator

Stephen J. Clarke, Director Area Cancer Services (Northern Sydney Cancer Centre), Kolling Institute of Medical Research and the Bill Walsh Cancer Research Laboratory, Royal North Shore Hospital and University of Sydney, Sydney, NSW

Professor of Medicine

Director Area Cancer Services (Northern Sydney Cancer Centre), Kolling Institute of Medical Research and the Bill Walsh Cancer Research Laboratory, Royal North Shore Hospital and University of Sydney

Andrew J. McLachlan, Faculty of Pharmacy and Centre for Education and Research on Ageing, University of Sydney and Concord Hospital, Sydney, NSW

Professor of Pharmacy (Aged Care)
Program Director, NHMRC Centre for Research Excellence in Medicines and Ageing

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Published

2017-07-27

Issue

Vol. 4 No. 3 (2017): July-September 2017

Section

Original Research Articles