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

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

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.

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.

12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.

No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.

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.

Zhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103.