Effect of acupuncture on lung cancer-related fatigue: Study protocol for a multi-center randomized controlled trial

Zhaoqin Wang, Shanshan Li, Luyi Wu, Qin Qi, Huirong Liu, Xiaoming Jin, Jianhui Tian, Ming Zhang, Xiaopeng Ma, Deli Sun, Shifen Xu, Huangan Wu

Research output: Contribution to journalArticle

Abstract

Background: Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design: This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion: This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: Http://www.chictr.org.cn/showproj.aspx?proj=37823

Original languageEnglish (US)
Article number625
JournalTrials
Volume20
Issue number1
DOIs
StatePublished - Nov 9 2019

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Acupuncture
Fatigue
Lung Neoplasms
Randomized Controlled Trials
Acupuncture Therapy
Clinical Protocols
Quality of Life
Neoplasms
Acupuncture Points
Intention to Treat Analysis
Therapeutics
Sample Size
Survivors
Registries
Clinical Trials
Organizations
Equipment and Supplies
Research

Keywords

  • Acupuncture
  • Cancer-related fatigue
  • Lung cancer
  • Multi-center randomized controlled trial
  • RCT

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Effect of acupuncture on lung cancer-related fatigue : Study protocol for a multi-center randomized controlled trial. / Wang, Zhaoqin; Li, Shanshan; Wu, Luyi; Qi, Qin; Liu, Huirong; Jin, Xiaoming; Tian, Jianhui; Zhang, Ming; Ma, Xiaopeng; Sun, Deli; Xu, Shifen; Wu, Huangan.

In: Trials, Vol. 20, No. 1, 625, 09.11.2019.

Research output: Contribution to journalArticle

Wang, Z, Li, S, Wu, L, Qi, Q, Liu, H, Jin, X, Tian, J, Zhang, M, Ma, X, Sun, D, Xu, S & Wu, H 2019, 'Effect of acupuncture on lung cancer-related fatigue: Study protocol for a multi-center randomized controlled trial', Trials, vol. 20, no. 1, 625. https://doi.org/10.1186/s13063-019-3701-0
Wang, Zhaoqin ; Li, Shanshan ; Wu, Luyi ; Qi, Qin ; Liu, Huirong ; Jin, Xiaoming ; Tian, Jianhui ; Zhang, Ming ; Ma, Xiaopeng ; Sun, Deli ; Xu, Shifen ; Wu, Huangan. / Effect of acupuncture on lung cancer-related fatigue : Study protocol for a multi-center randomized controlled trial. In: Trials. 2019 ; Vol. 20, No. 1.
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abstract = "Background: Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0{\%} in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design: This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion: This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: Http://www.chictr.org.cn/showproj.aspx?proj=37823",
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AU - Wang, Zhaoqin

AU - Li, Shanshan

AU - Wu, Luyi

AU - Qi, Qin

AU - Liu, Huirong

AU - Jin, Xiaoming

AU - Tian, Jianhui

AU - Zhang, Ming

AU - Ma, Xiaopeng

AU - Sun, Deli

AU - Xu, Shifen

AU - Wu, Huangan

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AB - Background: Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design: This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion: This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: Http://www.chictr.org.cn/showproj.aspx?proj=37823

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