BCI
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Sham-Controlled Trial
Sponsor study identifier
interventional
138
1 country
2
Study Start
November 18, 2019
Actual (reported)Primary Completion
January 30, 2022
Actual (reported)Study Completion
July 30, 2022
Actual (reported)The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2019
Actual (reported)October 30, 2019
Actual (reported)November 18, 2019
Actual (reported)January 30, 2022
Actual (reported)July 30, 2022
Actual (reported)Insomnia Severity Index (ISI)
The primary outcome will be the change of ISI score between the baseline and the end of the 6-week treatment. The ISI is a seven-item questionnaire devised to diagnose and assess the severity of insomnia.
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Actiwatch
Baseline, 6 week.
Sleep diary
Baseline, 6 week.
Pittsburgh Sleep Quality Index (PSQI)
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Hospital Anxiety and Depression Scale (HADS)
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Brief Pain Inventory-Short Form (BPI-SF)
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
12 sessions of acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
12 sessions of sham acupuncture treatment (SE+SA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.
EA: Ten points will be used, including GV24 (Shenting), GV20 (Baihui), EX-HN1 (Sishenchong), PC6 (Neiguan), CV12 (Zhongwan), CV4 (Guanyuan), ST25 (Tianshu), ST36 (Zusanli), SP6 (Sanyinjiao), KI3 (Taixi). AA: Vaccaria seeds will be embedded by acupuncturists on three auricular points (Shenmen, Sympathetic and Heart) and maintained between EA treatments.
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Hong Kong Sanatorium & Hospital
Hong Kong, 999077, Hong Kong
Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.
Savard J, Villa J, Ivers H, Simard S, Morin CM. Prevalence, natural course, and risk factors of insomnia comorbid with cancer over a 2-month period. J Clin Oncol. 2009 Nov 1;27(31):5233-9. doi: 10.1200/JCO.2008.21.6333. Epub 2009 Sep 8.
Zhang-Jin ZHANG, MMed, PhD
The University of Hong Kong
138 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
November 18, 2019
Actual (reported)Optimizing Functional Recovery of Breast Cancer Survivors
SE: The sham acupuncture treatment procedure, including the acupoint selection principle, sterilization procedure and treatment schedule, will be the same as in the acupuncture treatment group, except that sham points 1 to 2 cm exterior and inferior to the real points will be used, and no needle penetration or electric stimulation will be performed. SA: Three sham auricular points in the helix region (HX7, HX8, HX9) will be selected. Instead of Vaccaria seeds, soft Junci Medulla (1 to 2 mm in length, dyed black) will be used to mimic real AA with no pressure.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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Bao T, Goloubeva O, Pelser C, Porter N, Primrose J, Hester L, Sadowska M, Lapidus R, Medeiros M, Lao L, Dorsey SG, Badros AZ. A pilot study of acupuncture in treating bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Integr Cancer Ther. 2014 Sep;13(5):396-404. doi: 10.1177/1534735414534729. Epub 2014 May 26.
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Zou C, Yang L, Wu Y, Su G, Chen S, Guo X, Wu X, Liu X, Lin Q. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0122724. doi: 10.1371/journal.pone.0122724. eCollection 2015.
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Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the Insomnia Severity Index in cancer patients. Psychooncology. 2005 Jun;14(6):429-41. doi: 10.1002/pon.860.
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Mao H, Jin M, Xie L, Mao N, Shen X, Chen J, Chen X, Mao JJ, Shen X. Infrared laser moxibustion for cancer-related fatigue in breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2024 May 21;26(1):80. doi: 10.1186/s13058-024-01838-1.
Zhang J, Qin Z, So TH, Chang TY, Yang S, Chen H, Yeung WF, Chung KF, Chan PY, Huang Y, Xu S, Chiang CY, Lao L, Zhang ZJ. Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial. Breast Cancer Res. 2023 Apr 26;25(1):49. doi: 10.1186/s13058-023-01645-0.
Primary Completion
January 30, 2022
Actual (reported)Study Completion
July 30, 2022
Actual (reported)Last Updated
May 17, 2024
Record last verified: 2024-05
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