The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Detailed Description
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Hypothesis: Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control. Objective: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group. Design and strategy: This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list control. All patients in the 2 groups will receive routine Western medical care for symptom management. Study instrument: Insomnia Severity Index (ISI) will be employed as a primary outcome assessment. Intervention: In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list control group, no treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as treatment group. Main outcome measures: Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14. Secondary outcomes: Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer Therapy-Breast Cancer, and adverse events will be documented and compared between groups. Data analysis: The primary endpoint will be the continuous ISI score. For the primary analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test on the average ISI score will be performed to access the significance of the treatment effects; otherwise, a nonparametric approach will be taken. Expected outcome: ISI score of the acupuncture group is expected to be significantly lower than wait-list control group after 6 weeks of treatment.

Official Title
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The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study

Conditions
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Insomnia, Secondary, Breast Cancer Female, Chemotherapy

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients between 18 and 75 years of age; 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: Insomnia before the diagnosis of breast cancer; Other sleep disorder (e.g., obstructive sleep apnoea); 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); With pacemakers or other electronic implants that could interfere with electroacupuncture; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture (EA) and Auricular Acupuncture (AA)<br>12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization. | Device: Acupuncture<br>* Electroacupuncture (EA) and Auricular Acupuncture (AA)<br>|
| No Intervention: Wait-list control<br>No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) |  | week 0, 3, 6 (primary outcome), 10, 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index |  | week 0, 3, 6, 10, 14 | 
| Sleep diary |  | week 0, 6 | 
| Actigraphy |  | week 0, 6 | 
| Functional Assessment of Cancer Therapy-Breast Cancer |  | week 0, 6, 10, 14 | 
| Adverse events |  | week 0 to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Insomnia, Breast cancer, Chemotherapy