The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03762694|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Insomnia, Secondary Breast Cancer Female Chemotherapy||Device: Acupuncture||Not Applicable|
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.
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.
Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.
In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular acupressure) will be given twice a week for 6 weeks (2 chemotherapy cycle) 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, 9, 12.
Pittsburgh Sleep Quality Index, Sleep diary, Actigraphy, Functional Assessment of Cancer Therapy-Breast Cancer, EQ-5D-5L, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Electroacupuncture (EA) and Auricular Acupuncture (AA)
12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks (2 chemotherapy cycle) after randomization.
Electroacupuncture (EA) and Auricular Acupuncture (AA)
No Intervention: Wait-list control
No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.
- Change in Insomnia Severity Index (ISI) [ Time Frame: week 0, 3, 6, 9, 12 ]
- Pittsburgh Sleep Quality Index [ Time Frame: week 0, 3, 6, 9, 12 ]
- Sleep diary [ Time Frame: week 0, 3, 6, 9, 12 ]
- Actigraphy [ Time Frame: week 0, 6 ]
- Functional Assessment of Cancer Therapy-Breast Cancer [ Time Frame: week 0, 6, 9, 12 ]
- EQ-5D-5L [ Time Frame: week 0, 6, 9, 12 ]
- Adverse events [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762694
|Contact: Jialing Zhang||+852 9249 firstname.lastname@example.org|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|