NCT03762694

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Insomnia, Secondary
• Breast Cancer Female
• Chemotherapy

Interventions

Type	Name	Description
DEVICE	Acupuncture	Electroacupuncture (EA) and Auricular Acupuncture (AA)

Timeline

• Start date: 2019-03-26
• Primary completion: 2020-06-09
• Completion: 2020-10-31
• First posted: 2018-12-04
• Last updated: 2022-04-26

Locations

1 site across 1 country: Hong Kong