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Concomitant botanical medicine use among patients participating in commercial prostate cancer trials


Roydhouse, JK and Menapace, LA and Xia, H and Song, P and Berman, TJ and Agarwal, R and Suzman, DL and Wright, K and Beaver, JA and Kluetz, PG, Concomitant botanical medicine use among patients participating in commercial prostate cancer trials, Complementary Therapies in Medicine, 54 pp. 1-8. ISSN 0965-2299 (2020) [Refereed Article]

Copyright Statement

2020 Elsevier Ltd. All rights reserved.

DOI: doi:10.1016/j.ctim.2020.102549


Objectives: Patients with cancer frequently use botanical medications. The concomitant use of such medications by patients on commercial trials has not been well-described, despite the importance of these trials for evaluating the safety and efficacy of new agents. We sought to describe the use of botanical medications taken by patients with prostate cancer enrolled on global commercial trials.

Design: Retrospective study.

Setting: Regulatory repository of commercial clinical trial data.

Interventions: Anti-cancer therapy.

Main outcome measures: Botanical and medication use data were pooled across six international commercial randomized trials for metastatic prostate cancer with detailed information on medication and indications. Botanical products were considered to have potential for drug interaction if they led to a change in drug exposure in human trials. Potential for interaction was ascertained by PubMed review. Descriptive statistics were used for analysis.

Results: Of 7,318 enrolled patients, 700 (10%) reported botanical use at any time and 653 (9%) reported use of botanical products while on trial. Nearly half of botanical product types were not classified by plant (43%). The highest proportion of botanical use was among patients in Asian countries (32%), followed by patients in North America (13%). Eighty-six different types of botanical products were used; of these, nineteen had a patient-reported anti-cancer indication.

Conclusions: Botanical medicine use among patients with prostate cancer in commercial trials is moderate, although it varies by region. Practitioners should be aware of the use of botanical interventions in a clinical trial context.

Item Details

Item Type:Refereed Article
Keywords:prostate cancer, clinical trial, herbal, concomitant
Research Division:Biomedical and Clinical Sciences
Research Group:Oncology and carcinogenesis
Research Field:Oncology and carcinogenesis not elsewhere classified
Objective Division:Health
Objective Group:Clinical health
Objective Field:Clinical health not elsewhere classified
UTAS Author:Roydhouse, JK (Dr Jessica Roydhouse)
ID Code:140603
Year Published:2020
Deposited By:Menzies Institute for Medical Research
Deposited On:2020-08-31
Last Modified:2021-05-31

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