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.
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.