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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial

Authors: Yushu Zhou, Baiming Zhao, Wanyin Wu, Xiaobing Yang, Shunqin Long, Hong Deng, Wenfeng He, Guiya Liao, Qiuping Li, Zhen Xie

Published in: Trials | Issue 1/2018

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Abstract

Background

Cancer-related fatigue (CRF) is the most common symptom in patients with advanced non-small cell lung cancer (NSCLC) undergoing treatment with chemotherapy. However, evidence upon which to base management strategies is scarce. Traditional Chinese Medicine (TCM) has been shown to be beneficial to patients with CRF. Chinese herbal injections should be administered under an evidence-based approach. This trial aims to assess the efficacy and safety of the addition of the Shenmai injection (SMI) to conventional therapy for CRF in NSCLC patients undergoing chemotherapy.

Methods/design

The study is a two-group, prospective, randomized controlled trial (RCT) designed to evaluate the efficacy and safety of SMI for CRF NSCLC patients undergoing chemotherapy. Eligible participants will be randomized to either a treatment group receiving a 5-day Shenmai injection regimen plus conventional therapy or a control group receiving only conventional therapy. The primary outcome is fatigue, assessed using severity scores from the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F) measurement system. Secondary outcomes include symptom distress scores, depression, sleep disorders, quality of life, and levels of immunologic indicators. Assessments will be carried out at baseline and on day 5 (the end of the intervention).

Discussion

This study can provide evidence to support clinical decision-making in the management of CRF in NSCLC patients undergoing chemotherapy in a way that can be scaled up and used throughout China.

Trial registration

Chinese Clinical Trial Registry (chictr.​org.​cn), ChiCTR-INR-17013737. Registered on 6 December 2017.
Appendix
Available only for authorised users
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Metadata
Title
Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial
Authors
Yushu Zhou
Baiming Zhao
Wanyin Wu
Xiaobing Yang
Shunqin Long
Hong Deng
Wenfeng He
Guiya Liao
Qiuping Li
Zhen Xie
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2845-7

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