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
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 Medici...
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doaj-2819cd83bf95413780fc4de7200615372021-01-17T12:29:38ZengBMCTrials1745-62152020-01-012111910.1186/s13063-019-3982-3Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trialZhiwei Xiao0Leihao Hu1Jietao Lin2Liming Lu3Xuewu Huang4Xiaoshu Zhu5Chiahshean Teo6Lizhu Lin7Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou University of Chinese MedicineOncology Center, The First Affiliated Hospital of Guangzhou University of Chinese MedicineClinical Research Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese MedicineOncology Center, The First Affiliated Hospital of Guangzhou University of Chinese MedicineSchool of Science and Health,Chinese Medicine Centre, Western Sydney UniversityTraditional & Complementary Unit, National Cancer InstituteOncology Center, The First Affiliated Hospital of Guangzhou University of Chinese MedicineAbstract 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.https://doi.org/10.1186/s13063-019-3982-3Chemotherapy-related fatigueCancer-related fatigueNon-small cell lung cancerJianpishengsuiHerbal formula cream |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Zhiwei Xiao Leihao Hu Jietao Lin Liming Lu Xuewu Huang Xiaoshu Zhu Chiahshean Teo Lizhu Lin |
spellingShingle |
Zhiwei Xiao Leihao Hu Jietao Lin Liming Lu Xuewu Huang Xiaoshu Zhu Chiahshean Teo Lizhu Lin 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 Trials Chemotherapy-related fatigue Cancer-related fatigue Non-small cell lung cancer Jianpishengsui Herbal formula cream |
author_facet |
Zhiwei Xiao Leihao Hu Jietao Lin Liming Lu Xuewu Huang Xiaoshu Zhu Chiahshean Teo Lizhu Lin |
author_sort |
Zhiwei Xiao |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2020-01-01 |
description |
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. |
topic |
Chemotherapy-related fatigue Cancer-related fatigue Non-small cell lung cancer Jianpishengsui Herbal formula cream |
url |
https://doi.org/10.1186/s13063-019-3982-3 |
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