A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue i
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ORIGINAL ARTICLE – CANCER RESEARCH
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 Mauro Guglielmo1,5 · Patricia Di Pede1 · Salvatore Alfieri4 · Cristiana Bergamini4 · Francesca Platini4 · Carla Ida Ripamonti1 · Ester Orlandi3 · Nicola Alessandro Iacovelli3 · Lisa Licitra4 · Marta Maddalo2 · Paolo Bossi4 Received: 8 May 2020 / Accepted: 22 June 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
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. Keywords Head & neck cancer · Survivorship · Fatigue · American ginseng · Brief Fatigue Inventory
Introduction Marta Maddalo and Paolo Bossi: co-last Authors. * Mauro Guglielmo [email protected] 1
Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
2
Radiation Oncology Department, ASST Spedali Civili di Brescia - University of Brescia, Brescia, Italy
3
Radiation Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
4
Head and Neck Medical Oncology – Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy
5
Oncology Supportive Care in Cancer Unit, Medical Oncology & Haematology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Fatigue is defined as a distressing, persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to
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