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

• Published in: Complementary therapies in medicine 2020-11, Vol.54, p.102549-102549, Article 102549
• Main Authors: Roydhouse, J.K., Menapace, L.A., Xia, H., Song, P., Berman, T., Agarwal, R., Suzman, D.L., Wright, K., Beaver, J.A., Kluetz, P.G.
• Format: Article
• Language: English
• Subjects: Botanical; Cancer therapies; Clinical trial; Clinical trials; Concomitant; Datasets; Dictionaries; Drug interaction; Drug interactions; FDA approval; Human subjects; Laxatives; Marketing; Medicine; Metastases; Patients; Prostate cancer; Regulatory approval; Statistical analysis
• ISSN: 0965-2299; 1873-6963
• DOI: 10.1016/j.ctim.2020.102549

•Use of concomitant botanical products by patients with prostate cancer enrolled on commercial clinical trials is moderate (10 %).•However, use can be high in some regions and countries.•Protocols and post-marketing materials do discuss the use of concomitant botanical products. 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. Retrospective study. Regulatory repository of commercial clinical trial data. Anti-cancer therapy. 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. Of 7318 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. 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.