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Published in: Journal of Cancer Research and Clinical Oncology 10/2020

01-10-2020 | Cancer Fatigue | 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

Authors: Mauro Guglielmo, Patricia Di Pede, Salvatore Alfieri, Cristiana Bergamini, Francesca Platini, Carla Ida Ripamonti, Ester Orlandi, Nicola Alessandro Iacovelli, Lisa Licitra, Marta Maddalo, Paolo Bossi

Published in: Journal of Cancer Research and Clinical Oncology | Issue 10/2020

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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.
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Metadata
Title
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
Authors
Mauro Guglielmo
Patricia Di Pede
Salvatore Alfieri
Cristiana Bergamini
Francesca Platini
Carla Ida Ripamonti
Ester Orlandi
Nicola Alessandro Iacovelli
Lisa Licitra
Marta Maddalo
Paolo Bossi
Publication date
01-10-2020
Publisher
Springer Berlin Heidelberg
Published in
Journal of Cancer Research and Clinical Oncology / Issue 10/2020
Print ISSN: 0171-5216
Electronic ISSN: 1432-1335
DOI
https://doi.org/10.1007/s00432-020-03300-z

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