Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
NCT ID: NCT04144309
Last Updated: 2024-05-17
Study Results
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Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2019-11-18
2022-07-30
Brief Summary
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Detailed Description
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Acupuncture has been used for thousands of years to treat various diseases, including insomnia. Our previous research demonstrated the efficacy and safety of acupuncture as a treatment for insomnia. However, the effect of acupuncture on insomnia in breast cancer patients who undergo chemotherapy has been rarely studied. We propose this randomized controlled trial to examine the feasibility, effect and safety of acupuncture as a treatment for insomnia in breast cancer patients who undergo chemotherapy.
Hypothesis: We hypothesize that acupuncture is a feasible, effective and safe method for the alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a sham control.
Primary Aim: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the sham control group, as measured by the ISI after 6 weeks of treatment.
Secondary Aims: 1) To determine whether other sleep-related parameters in the acupuncture group improve more than those of the control group, as measured at different time points by Actiwatch, sleep diary, Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and Brief Pain Inventory (BPI). 2) To assess by adverse event (AE) analysis whether acupuncture is safe for treatment of insomnia in breast cancer patients undergoing chemotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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True acupuncture group
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.
Electroacupuncture (EA) and Auricular Acupressure (AA)
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.
Sham acupuncture group
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.
Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)
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.
Interventions
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Electroacupuncture (EA) and Auricular Acupressure (AA)
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.
Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer.
* Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months.
* Insomnia onset after the diagnosis of breast cancer.
* Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks.
* Expected survival time of more than 6 months.
* Ability to understand the nature of the study and willingness to give informed consent.
* Ability to provide responses during outcome measurement.
Exclusion Criteria
* Shift work or irregular sleep pattern.
* Severe visual, hearing or language defects.
* Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL).
* History of acupuncture use in the previous 3 months.
* Participation in other clinical trials with intervention within 3 months of the beginning of the trial.
18 Years
75 Years
FEMALE
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Prof. Zhang Zhang-Jin
Professor
Principal Investigators
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Zhang-Jin ZHANG, MMed, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, , Hong Kong
Hong Kong Sanatorium & Hospital
Hong Kong, , Hong Kong
Countries
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References
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Other Identifiers
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UW 19-045
Identifier Type: -
Identifier Source: org_study_id
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