Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer (AA)

May 7, 2025 updated by: Chang Gung Memorial Hospital

Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular Acupressure (AA)
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.
Behavioral: Auricular Acupressure with Vaccaria Seeds
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 Comparator: Sham Auricular Acupressure
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.
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 points. Procedures, duration, frequency, and sleep hygiene education are identical to those in the experimental group to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8, Week 12, and follow-up at Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Assessed by BFI-T
Time Frame: Baseline, Week 4, Week 8, Week 12
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).
Baseline, Week 4, Week 8, Week 12
Anxiety and Depression (assessed by HADS)
Time Frame: Baseline, Week 4, Week 8, Week 12
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.
Baseline, Week 4, Week 8, Week 12
Hypnotic Medication Use
Time Frame: Week 4, Week 8, Week 12
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.
Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202500593B0
  • KH20250422001 (Other Identifier: Kaohsiung Chang Gung Memorial Hospital, Taiwan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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