Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial
Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this t...
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| Format: | Article |
| Language: | English |
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BMC
2020-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04721-4 |
| _version_ | 1811322300093431808 |
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| author | Hongyu Yue Shuang Zhou Huangan Wu Xuan Yin Shanshan Li Tingting Liang Yan Li Zhihong Fang Xufeng Zhang Linglin Wang Min Han Xiaolei Chen Ming Zhang Wei Zhang Zhangjin Zhang Shifen Xu |
| author_facet | Hongyu Yue Shuang Zhou Huangan Wu Xuan Yin Shanshan Li Tingting Liang Yan Li Zhihong Fang Xufeng Zhang Linglin Wang Min Han Xiaolei Chen Ming Zhang Wei Zhang Zhangjin Zhang Shifen Xu |
| author_sort | Hongyu Yue |
| collection | DOAJ |
| description | Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068 |
| first_indexed | 2024-04-13T13:32:44Z |
| format | Article |
| id | doaj.art-885bdf2ed9664e24ae067a62e47f0dd2 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T13:32:44Z |
| publishDate | 2020-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-885bdf2ed9664e24ae067a62e47f0dd22022-12-22T02:44:53ZengBMCTrials1745-62152020-09-0121111010.1186/s13063-020-04721-4Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trialHongyu Yue0Shuang Zhou1Huangan Wu2Xuan Yin3Shanshan Li4Tingting Liang5Yan Li6Zhihong Fang7Xufeng Zhang8Linglin Wang9Min Han10Xiaolei Chen11Ming Zhang12Wei Zhang13Zhangjin Zhang14Shifen Xu15Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineAcupuncture and Moxibusion College, Shanghai University of Traditional Chinese MedicineResearch Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicinePutuo Hospital, Shanghai University of Traditional Chinese MedicinePutuo Hospital, Shanghai University of Traditional Chinese MedicinePutuo Hospital, Shanghai University of Traditional Chinese MedicineXie-Tu Community Health Service CentreShanghai Chest Hospital, Shanghai Jiao Tong UniversityDepartment of Biostatistics, School of Public Health, Fudan UniversitySchool of Chinese Medicine, The University of Hong KongShanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese MedicineAbstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068http://link.springer.com/article/10.1186/s13063-020-04721-4RCTProtocolEALung cancer-related insomnia |
| spellingShingle | Hongyu Yue Shuang Zhou Huangan Wu Xuan Yin Shanshan Li Tingting Liang Yan Li Zhihong Fang Xufeng Zhang Linglin Wang Min Han Xiaolei Chen Ming Zhang Wei Zhang Zhangjin Zhang Shifen Xu Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial Trials RCT Protocol EA Lung cancer-related insomnia |
| title | Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial |
| title_full | Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial |
| title_fullStr | Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial |
| title_full_unstemmed | Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial |
| title_short | Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial |
| title_sort | efficacy and safety of electro acupuncture ea on insomnia in patients with lung cancer study protocol of a randomized controlled trial |
| topic | RCT Protocol EA Lung cancer-related insomnia |
| url | http://link.springer.com/article/10.1186/s13063-020-04721-4 |
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