Article: Roydhouse JK, Menapace LA, Xia H, Song P, Berman T, Agarwal R, et al. Concomitant botanical medicine use among patients participating in commercial prostate cancer trials. Complement Ther Med. 2020;54:102549.

Abstract: 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 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.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.

Review: Clinical trial results may be impacted by intake of other agents such as botanical medications outside of the anti-cancer therapy being studied. A large retrospective study of international randomized trial data for metastatic prostate cancer was examined for patient-reported botanical use. Nine percent of the sample had used botanicals while on trial. Prevalence was higher in Asian countries (32%) and North America (13%). Research teams should assess participants for botanical use which may produce drug interactions and be aware that regional differences are influential. 

Article: Guglielmo, M., et al. (2020). "A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer." J Cancer Res Clin Oncol 146(10): 2479-2487.

Abstract: Purpose: Fatigue is a distressing symptom in head & neck cancer patients before, during and at the end of curative therapy. Pharmacologic and not pharmacologic treatments have been proposed with scarce or no evidence of efficacy. The aim of the study is to evaluate the efficacy of American ginseng in respect to placebo in reducing fatigue in patients treated for head and neck cancer with curative intent. Methods: Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1 year and had a global fatigue score > 4 by means of Brief Fatigue Inventory (BFI) were randomized to receive 1000 mg of American ginseng or placebo per day for 8 weeks with the aim to assess their efficacy. Changes in fatigue scores in the 2 subgroups of patients before and after the treatment with American ginseng or placebo, were assessed by the BFI at baseline and at the end of week 8. Results: The mean of the mean values of the BFI measured at 8 weeks (end of treatment) was 4.6 in the Ginseng arm and 3.4 in the Placebo arm (p = ns). Mean comparison showed a tendency to statistical significance only for the single item on interference with general activity (p = 0.06), with better performance for placebo. The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire. Conclusion: The present data shows that American ginseng has insufficient evidence to be recommended for Cancer Related Fatigue (CRF) in post treatment HNC survivors.

Review: Randomized, double-blind, placebo-controlled trials are the gold standard for research on the effectiveness of interventions on health outcomes. In this case, American Ginseng was compared to placebo for fatigue in head & neck cancer patients. The ginseng intervention did not perform better than the placebo, indicating that there is not enough clinical evidence to recommend ginseng for fatigue. Dietary supplements should continue to be rigorously examined for effectiveness in diverse populations to assist clinicians and practitioners in therapeutic recommendations.