Breast Cancer Sleep Disorders Sleep Disturbance InsomniaAANCT06964945
Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer
A study testing Auricular Acupressure with Vaccaria Seeds in people with Breast Cancer Sleep Disorders Sleep Disturbance Insomnia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Abstract Background: Sleep disturbances are highly prevalent among breast cancer (BC) patients, especially during chemotherapy, significantly affecting quality of life and treatment adherence. Conventional pharmacologic treatments for sleep disorders may cause side effects and are not always effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Sleep Disorders Sleep Disturbance Insomnia
- What is being tested?
- Auricular Acupressure with Vaccaria Seeds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18 years or older
- Histologically confirmed stage I-III breast cancer
- Scheduled to undergo at least four cycles of adjuvant or neoadjuvant chemotherapy or currently receiving hormone therapy
- Pittsburgh Sleep Quality Index (PSQI) score < 5 at baseline (indicating no pre-existing sleep disorder)
- Able to provide informed consent and comply with study procedures
Who cannot join
- Pregnant or breastfeeding
- Diagnosed with stage IIIB, inflammatory, or metastatic breast cancer
- Pre-existing anemia or hematologic disorders
- History of alcohol or substance abuse
- Diagnosed endocrine disorders or other medical conditions affecting sleep
- Active psychiatric disorders interfering with participation
- Skin lesions, infections, or allergy to adhesive patches on both ears
- Currently undergoing other complementary sleep-related therapies (e.g., aromatherapy, massage, herbal medicine, health supplements)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Chia-Wen Chuang, PhD Candidate, +88677317123 ext. 2026, mavis20023@hotmail.com
About this study
Official title: Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial
Abstract
Background:
Read more
Sleep disturbances are highly prevalent among breast cancer (BC) patients, especially during chemotherapy, significantly affecting quality of life and treatment adherence. Conventional pharmacologic treatments for sleep disorders may cause side effects and are not always effective. Auricular acupressure (AA), a non-invasive alternative therapy, has demonstrated promising effects on sleep improvement. However, high-quality evidence for its use in BC patients remains limited.
Objective:
This study aims to evaluate the effectiveness of auricular acupressure in preventing sleep disturbances in breast cancer patients undergoing chemotherapy.
Methods:
This double-blind, randomized, sham-controlled trial will recruit 128 participants diagnosed with stage I-III breast cancer who are undergoing chemotherapy or hormone therapy. Eligible participants will be randomly assigned in a 1:1 ratio to receive either auricular acupressure (AA) or sham AA, in addition to usual care. The intervention will be administered over a 12-week period, followed by a 4-week follow-up.
In the AA group, Vaccaria seeds will be applied to five specific auricular acupoints. In the sham AA group, identical adhesive patches without seeds will be applied to the same acupoints. Both groups will receive the same treatment schedule and standardized care instructions to ensure blinding.
The primary outcome is sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) at baseline, and at weeks 4, 8, 12, and 16. Secondary outcomes include fatigue (measured by the BFI-T), anxiety and depression (measured by the HADS), and hypnotic medication use, assessed at baseline, and at weeks 4, 8, and 12.
Statistical analysis will be performed using Generalized Estimating Equations (GEE) to examine changes over time and between groups.
Expected Results:
We hypothesize that AA will significantly improve sleep quality and reduce symptom burden compared to sham AA in BC patients.
Conclusion:
This study will provide rigorous evidence on the efficacy and safety of auricular acupressure as a complementary intervention for sleep disturbance prevention in breast cancer patients receiving chemotherapy.
Read the detailed description
Breast cancer (BC) patients frequently experience sleep disturbances throughout the treatment continuum, with prevalence rates as high as 60-87%. These disturbances are associated with increased physical and psychological burden, impaired treatment adherence, and reduced quality of life. Chemotherapy and hormone therapy, particularly those involving corticosteroids such as dexamethasone, have been identified as major contributors to sleep disruption. Although pharmacological approaches are commonly used to manage sleep issues, they are often accompanied by side effects and limited long-term efficacy.
Auricular acupressure (AA), a non-invasive technique derived from Traditional Chinese Medicine, involves stimulating specific ear points using Vaccaria seeds to regulate neurohumoral function. Previous studies have demonstrated its effectiveness in general populations with insomnia, but rigorous evidence supporting its role in cancer-related sleep disturbance-especially among BC patients-remains limited.
This double-blind, randomized, sham-controlled trial aims to evaluate the effectiveness of AA in preventing sleep disturbances in BC patients undergoing chemotherapy or hormone therapy. A total of 128 participants with stage I-III BC and no pre-existing sleep disorders will be randomized in a 1:1 ratio to receive either AA or sham AA over a 12-week period. Vaccaria seeds will be applied to five auricular points in the intervention group, while identical patches without seeds will be used in the sham group. Both groups will receive standardized sleep hygiene education.
The primary outcome is sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include fatigue (BFI-T), anxiety and depression (HADS), and hypnotic medication use. Assessments will be conducted at baseline and during follow-up at weeks 4, 8, 12, and 16. Statistical analysis will use Generalized Estimating Equations (GEE) to compare changes over time between groups.
This study is expected to provide high-quality evidence on the use of AA as a complementary strategy for sleep disturbance prevention in BC patients, addressing a critical yet under-recognized aspect of supportive cancer care.
- Being tested
- Auricular Acupressure with Vaccaria Seeds, Sham Auricular Acupressure (No Seeds)
- Keywords
- Auricular acupressure, Breast cancer, Sleep disturbance
- Medical subject headings
- Breast Neoplasms, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupressure with Vaccaria SeedsBehavioural
Auricular Acupressure with Vaccaria Seeds Participants in this group receive auricular acupressure using 2 mm Vaccaria seeds adhered to five specific auricular acupoints (TF4, CO15, Extra5, LO4, LO4) with 7 mm × 7 mm adhesive patches. Each session lasts 10-20 minutes, with seeds left in place for 5-7 days. A total of 12 weeks, along with standardized sleep hygiene education.
Sham Auricular Acupressure (No Seeds)Behavioural
Participants in this group receive sham auricular acupressure using identical adhesive patches without Vaccaria seeds, applied to the same five auricular points. Procedures, duration, frequency, and sleep hygiene education are identical to those in the experimental group to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupressure (AA) | Experimental | Participants in this group receive auricular acupressure using Vaccaria seeds applied to five specific auricular acupoints over 12 weeks. All participants also receive standard sleep hygiene education. Receives: Behavioral: Auricular Acupressure with Vaccaria Seeds |
| Sham Auricular Acupressure | Sham comparator | Participants in this group receive sham auricular acupressure using identical adhesive patches without Vaccaria seeds applied to the same five auricular acupoints. The procedure mimics the true intervention in appearance, duration, and frequency, maintaining participant blinding. All participants also receive standardized sleep hygiene education. Receives: Behavioral: Sham Auricular Acupressure (No Seeds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbance assessed by PSQI
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire.
Measured: Baseline, Week 4, Week 8, Week 12, and follow-up at Week 16
Secondary outcomes (3)
Fatigue Severity Assessed by BFI-T
Fatigue will be assessed using the Brief Fatigue Inventory - Traditional Chinese version (BFI-T), a 9-item self-report scale measuring fatigue severity and interference. Scores range from 0 (no fatigue) to 10 (severe fatigue).
Measured: Baseline, Week 4, Week 8, Week 12
Anxiety and Depression (assessed by HADS)
Emotional distress will be measured using the Hospital Anxiety and Depression Scale (HADS), consisting of two subscales: HADS-A for anxiety and HADS-D for depression. Each subscale includes 7 items scored from 0 to 21.
Measured: Baseline, Week 4, Week 8, Week 12
Hypnotic Medication Use
Participants will record daily use of hypnotic medications, including benzodiazepines, non-benzodiazepines, antidepressants, melatonin receptor agonists, and other sleep aids. Data will be summarized as weekly usage scores.
Measured: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Sleep Disorders Sleep Disturbance InsomniaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the auricular acupressure group or the sham control group using stratified block randomization based on hormone receptor status and menopausal status. Each participant receives only one type of intervention throughout the 12-week period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964945
- Sponsor's protocol ID
- 202500593B0
- Other IDs
- KH20250422001
- Acronym
- AA
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including demographic variables (e.g., age, menopausal status), group assignment (intervention vs. control), and outcome measures such as PSQI scores, BFI-T scores, HADS scores, and hypnotic medication use will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06964945
- Acronym / sponsor ID
- AA / 202500593B0
- Keywords
- Auricular acupressure, Breast cancer, Sleep disturbance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2025 (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.
Abstract
Background:
Sleep disturbances are highly prevalent among breast cancer (BC) patients, especially during chemotherapy, significantly affecting quality of life and treatment adherence. Conventional pharmacologic treatments for sleep disorders may cause side effects and are not always effective. Auricular acupressure (AA), a non-invasive alternative therapy, has demonstrated promising effects on sleep improvement. However, high-quality evidence for its use in BC patients remains limited.
Objective:
This study aims to evaluate the effectiveness of auricular acupressure in preventing sleep disturbances in breast cancer patients undergoing chemotherapy.
Methods:
This double-blind, randomized, sham-controlled trial will recruit 128 participants diagnosed with stage I-III breast cancer who are undergoing chemotherapy or hormone therapy. Eligible participants will be randomly assigned in a 1:1 ratio to receive either auricular acupressure (AA) or sham AA, in addition to usual care. The intervention will be administered over a 12-week period, followed by a 4-week follow-up.
In the AA group, Vaccaria seeds will be applied to five specific auricular acupoints. In the sham AA group, identical adhesive patches without seeds will be applied to the same acupoints. Both groups will receive the same treatment schedule and standardized care instructions to ensure blinding.
The primary outcome is sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) at baseline, and at weeks 4, 8, 12, and 16. Secondary outcomes include fatigue (measured by the BFI-T), anxiety and depression (measured by the HADS), and hypnotic medication use, assessed at baseline, and at weeks 4, 8, and 12.
Statistical analysis will be performed using Generalized Estimating Equations (GEE) to examine changes over time and between groups.
Expected Results:
We hypothesize that AA will significantly improve sleep quality and reduce symptom burden compared to sham AA in BC patients.
Conclusion:
This study will provide rigorous evidence on the efficacy and safety of auricular acupressure as a complementary intervention for sleep disturbance prevention in breast cancer patients receiving chemotherapy.
Detailed description
Breast cancer (BC) patients frequently experience sleep disturbances throughout the treatment continuum, with prevalence rates as high as 60-87%. These disturbances are associated with increased physical and psychological burden, impaired treatment adherence, and reduced quality of life. Chemotherapy and hormone therapy, particularly those involving corticosteroids such as dexamethasone, have been identified as major contributors to sleep disruption. Although pharmacological approaches are commonly used to manage sleep issues, they are often accompanied by side effects and limited long-term efficacy.
Auricular acupressure (AA), a non-invasive technique derived from Traditional Chinese Medicine, involves stimulating specific ear points using Vaccaria seeds to regulate neurohumoral function. Previous studies have demonstrated its effectiveness in general populations with insomnia, but rigorous evidence supporting its role in cancer-related sleep disturbance-especially among BC patients-remains limited.
This double-blind, randomized, sham-controlled trial aims to evaluate the effectiveness of AA in preventing sleep disturbances in BC patients undergoing chemotherapy or hormone therapy. A total of 128 participants with stage I-III BC and no pre-existing sleep disorders will be randomized in a 1:1 ratio to receive either AA or sham AA over a 12-week period. Vaccaria seeds will be applied to five auricular points in the intervention group, while identical patches without seeds will be used in the sham group. Both groups will receive standardized sleep hygiene education.
The primary outcome is sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include fatigue (BFI-T), anxiety and depression (HADS), and hypnotic medication use. Assessments will be conducted at baseline and during follow-up at weeks 4, 8, 12, and 16. Statistical analysis will use Generalized Estimating Equations (GEE) to compare changes over time between groups.
This study is expected to provide high-quality evidence on the use of AA as a complementary strategy for sleep disturbance prevention in BC patients, addressing a critical yet under-recognized aspect of supportive cancer care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the auricular acupressure group or the sham control group using stratified block randomization based on hormone receptor status and menopausal status. Each participant receives only one type of intervention throughout the 12-week period.
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure (AA) | Experimental | Behavioral: Auricular Acupressure with Vaccaria SeedsParticipants in this group receive auricular acupressure using Vaccaria seeds applied to five specific auricular acupoints over 12 weeks. All participants also receive standard sleep hygiene education. |
| Sham Auricular Acupressure | Sham comparator | Behavioral: Sham Auricular Acupressure (No Seeds)Participants in this group receive sham auricular acupressure using identical adhesive patches without Vaccaria seeds applied to the same five auricular acupoints. The procedure mimics the true intervention in appearance, duration, and frequency, maintaining participant blinding. All participants also receive standardized sleep hygiene education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, aged 18 years or older
- Histologically confirmed stage I-III breast cancer
- Scheduled to undergo at least four cycles of adjuvant or neoadjuvant chemotherapy or currently receiving hormone therapy
- Pittsburgh Sleep Quality Index (PSQI) score < 5 at baseline (indicating no pre-existing sleep disorder)
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding
- Diagnosed with stage IIIB, inflammatory, or metastatic breast cancer
- Pre-existing anemia or hematologic disorders
- History of alcohol or substance abuse
- Diagnosed endocrine disorders or other medical conditions affecting sleep
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 |
|---|---|---|
| Auricular Acupressure with Vaccaria SeedsAuricular Acupressure with Vaccaria Seeds Participants in this group receive auricular acupressure using 2 mm Vaccaria seeds adhered to five specific auricular acupoints (TF4, CO15, Extra5, LO4, LO4) with 7 mm × 7 mm adhesive patches. Each session lasts 10-20 minutes, with seeds left in place for 5-7 days. A total of 12 weeks, along with standardized sleep hygiene education. | Behavioural | Auricular Acupressure (AA) |
| Sham Auricular Acupressure (No Seeds)Participants in this group receive sham auricular acupressure using identical adhesive patches without Vaccaria seeds, applied to the same five auricular points. Procedures, duration, frequency, and sleep hygiene education are identical to those in the experimental group to maintain blinding. | Behavioural | Sham Auricular Acupressure |
Primary outcome
Sleep disturbance assessed by PSQI
Time frame: Baseline, Week 4, Week 8, Week 12, and follow-up at Week 16
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire.
3 secondary outcomes
Fatigue Severity Assessed by BFI-T
Time frame: Baseline, Week 4, Week 8, Week 12
Anxiety and Depression (assessed by HADS)
Time frame: Baseline, Week 4, Week 8, Week 12
Hypnotic Medication Use
Time frame: Week 4, Week 8, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including demographic variables (e.g., age, menopausal status), group assignment (intervention vs. control), and outcome measures such as PSQI scores, BFI-T scores, HADS scores, and hypnotic medication use will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure with Vaccaria Seeds in people with Breast Cancer Sleep Disorders Sleep Disturbance Insomnia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 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: opening soon, as of the sponsor's last update on 11 May 2025. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Wen Chuang, PhD Candidate (+88677317123 ext. 2026, mavis20023@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbance assessed by PSQI (time frame: Baseline, Week 4, Week 8, Week 12, and follow-up at Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025.