Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer

NCT ID: NCT06964945

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief 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. 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.

Conditions

Breast Cancer Sleep Disorders Sleep Disturbance Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Auricular Acupressure with Vaccaria Seeds

Intervention Type: BEHAVIORAL

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

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.

Group Type: SHAM_COMPARATOR

Sham Auricular Acupressure (No Seeds)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Chia-Wen Chuang, PhD Candidate

Role: CONTACT

mavis20023@hotmail.com

+88677317123 ext. 2026

Facility Contacts

Chia-Wen Chuang, PhD Candidate

Role: primary

mavis20023@hotmail.com

+88677317123 ext. 2026

Other Identifiers

KH20250422001

Identifier Type: OTHER

Identifier Source: secondary_id

202500593B0

Identifier Type: -

Identifier Source: org_study_id