Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:06 AM
Study NCT ID:
NCT03762694
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2018-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: