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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

Overview of attention for article published in Trials, September 2018
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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
Published in
Trials, September 2018
DOI 10.1186/s13063-018-2845-7
Pubmed ID
Authors

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

Abstract

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. 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). 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. Chinese Clinical Trial Registry ( chictr.org.cn ), ChiCTR-INR-17013737 . Registered on 6 December 2017.

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Mendeley readers

The data shown below were compiled from readership statistics for 131 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 131 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 22 17%
Student > Ph. D. Student 16 12%
Student > Master 10 8%
Researcher 9 7%
Other 8 6%
Other 17 13%
Unknown 49 37%
Readers by discipline Count As %
Medicine and Dentistry 29 22%
Nursing and Health Professions 17 13%
Psychology 14 11%
Biochemistry, Genetics and Molecular Biology 4 3%
Agricultural and Biological Sciences 3 2%
Other 11 8%
Unknown 53 40%