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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | NSCLC | Study protocol

Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial

Authors: Zhiwei Xiao, Leihao Hu, Jietao Lin, Liming Lu, Xuewu Huang, Xiaoshu Zhu, Chiahshean Teo, Lizhu Lin

Published in: Trials | Issue 1/2020

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Abstract

Background

Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response. Due to the lack of high-quality clinical evidence, a randomized placebo-controlled trial is required to assess the efficacy and safety of JPSS.

Methods/design

The efficacy and safety of JPSS herbal formula cream will be evaluated through a prospective, randomized, placebo-controlled trial conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. NSCLC patients with CRF will be randomized into two groups at a ratio of 1:1. Each group will receive either 15 g of the oral JPSS herbal formula cream or placebo twice a day from day 6 to day 20 during two courses of paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy. The primary endpoint is the difference in the degree of fatigue between baseline (the day before the start of the intervention) and day 42, which will be assessed by the Revised Piper Fatigue Scale score. The secondary endpoints are quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score. The toxicity of the treatments will also be evaluated at the same time. All outcomes will be measured at baseline, day 6, day 21, and day 42 of the treatment.

Discussion

This randomized trial will investigate the efficacy and safety of JPSS applied for CRF in patients with NSCLC.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1900023451​. Registered on 28 May 2019.
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Metadata
Title
Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial
Authors
Zhiwei Xiao
Leihao Hu
Jietao Lin
Liming Lu
Xuewu Huang
Xiaoshu Zhu
Chiahshean Teo
Lizhu Lin
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3982-3

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