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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Cancer Fatigue | Study protocol

5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment

Authors: Mojtaba Miladinia, Mina Jahangiri, Sharon Jackson White, Hossein Karimpourian, Alessandro Inno, Sally Wai-Chi Chan, Reza Ganji, Mahmood Maniati, Kourosh Zarea, Marziyeh Ghalamkari, Ali Farahat, Cecilia Fagerström

Published in: Trials | Issue 1/2024

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Abstract

Background

Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer.

Methods

The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0–10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups.

Discussion

The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines.

Trial registration

IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.
Appendix
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Metadata
Title
5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment
Authors
Mojtaba Miladinia
Mina Jahangiri
Sharon Jackson White
Hossein Karimpourian
Alessandro Inno
Sally Wai-Chi Chan
Reza Ganji
Mahmood Maniati
Kourosh Zarea
Marziyeh Ghalamkari
Ali Farahat
Cecilia Fagerström
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08078-w

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