Insomnia, SecondaryNCT03762694
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
A study testing Acupuncture in people with Insomnia, Secondary and Breast Cancer Female, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Insomnia, Secondary, Breast Cancer Female, Chemotherapy
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Mar 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients between 18 and 75 years of age;
- Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
- Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
- Insomnia onset after the diagnosis of breast cancer;
- 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;
- Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;
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- Expected survival time of more than 6 months;
- Ability to understand the nature of the study and willingness to give informed consent;
- Ability to provide responses during outcome measurement.
Who cannot join
- Insomnia before the diagnosis of breast cancer;
- Other sleep disorder (e.g., obstructive sleep apnoea);
- Shift work or irregular sleep pattern;
- Severe visual, hearing or language defects;
- Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);
- With pacemakers or other electronic implants that could interfere with electroacupuncture;
- History of acupuncture use in the previous 3 months;
- Participation in other clinical trials with intervention within 3 months of the beginning of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study
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.
Read the 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
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Insomnia, Breast cancer, Chemotherapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Electroacupuncture (EA) and Auricular Acupuncture (AA)
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) and Auricular Acupuncture (AA) | Experimental | 12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization. Receives: Device: Acupuncture |
| Wait-list control | No intervention | No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)
Measured: week 0, 3, 6 (primary outcome), 10, 14
Secondary outcomes (5)
Pittsburgh Sleep Quality Index
Measured: week 0, 3, 6, 10, 14
Sleep diary
Measured: week 0, 6
Actigraphy
Measured: week 0, 6
Functional Assessment of Cancer Therapy-Breast Cancer
Measured: week 0, 6, 10, 14
Adverse events
Measured: week 0 to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start26 Mar 2019
- Primary completion9 Jun 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia, SecondaryStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor LAO Lixing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762694
- Sponsor's protocol ID
- UW 18-526
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2018
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103.
PubMed 34036813
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03762694
- Acronym / sponsor ID
- UW 18-526
- Conditions
- Insomnia, Secondary, Breast Cancer Female, Chemotherapy
- Keywords
- Acupuncture, Insomnia, Breast cancer, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) and Auricular Acupuncture (AA) | Experimental | Device: Acupuncture12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization. |
| Wait-list control | No intervention | –No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients between 18 and 75 years of age;
- Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
- Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
- Insomnia onset after the diagnosis of breast cancer;
- 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;
Key exclusion criteria (8 listed)
- Insomnia before the diagnosis of breast cancer;
- Other sleep disorder (e.g., obstructive sleep apnoea);
- Shift work or irregular sleep pattern;
- Severe visual, hearing or language defects;
- Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureElectroacupuncture (EA) and Auricular Acupuncture (AA) | Device | Electroacupuncture (EA) and Auricular Acupuncture (AA) |
Primary outcome
Change in Insomnia Severity Index (ISI)
Time frame: week 0, 3, 6 (primary outcome), 10, 14
5 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: week 0, 3, 6, 10, 14
Sleep diary
Time frame: week 0, 6
Actigraphy
Time frame: week 0, 6
Functional Assessment of Cancer Therapy-Breast Cancer
Time frame: week 0, 6, 10, 14
Adverse events
Time frame: week 0 to week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 34036813Zhang J, Qin Z, So TH, Chen H, Lam WL, Yam LL, Yan Chan P, Lao L, Zhang ZJ. Electroacupuncture Plus Auricular Acupressure for Chemotherapy-Associated Insomnia in Breast Cancer Patients: A Pilot Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019103. doi: 10.1177/15347354211019103.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Insomnia, Secondary and Breast Cancer Female, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) (time frame: week 0, 3, 6 (primary outcome), 10, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.