the effect of acupuncture for insomnia in breast cancer patients undergoing chemotherapy

Conditions: Insomnia, Secondary; Breast Cancer Female; Chemotherapy

Summary: 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.

Eligibility criteria:
inclusion criteria: 1. female patients between 18 and 75 years of age; 2. diagnosis of stage (american joint committee on cancer (ajcc) tnm) i-iv breast cancer; 3. currently receiving chemotherapy, or have completed chemotherapy no more than 6 months; 4. insomnia onset after the diagnosis of breast cancer; 5. 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; 6. insomnia severity as defined by an isi score of no less than 10 in the past 2 weeks; 7. expected survival time of more than 6 months; 8. ability to understand the nature of the study and willingness to give informed consent; 9. ability to provide responses during outcome measurement. exclusion criteria: 1. insomnia before the diagnosis of breast cancer; 2. other sleep disorder (e.g., obstructive sleep apnoea); 3. shift work or irregular sleep pattern; 4. severe visual, hearing or language defects; 5. severe hematological dysfunction (platelet count \<60,000/μl, haemoglobin \<8 g/dl or absolute neutrophil count \<1000/μl); 6. with pacemakers or other electronic implants that could interfere with electroacupuncture; 7. history of acupuncture use in the previous 3 months; 8. participation in other clinical trials with intervention within 3 months of the beginning of the trial.

Keywords: acupuncture insomnia breast cancer chemotherapy