Clinical trial NCT06964945: Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer
Official title: Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Sleep Disorders Sleep Disturbance Insomnia
Keywords: Auricular acupressure, Breast cancer, Sleep disturbance
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Sleep disturbance assessed by PSQI
timeFrame: Baseline, Week 4, Week 8, Week 12, and follow-up at Week 16
Secondary outcomes:
measure: Fatigue Severity Assessed by BFI-T
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Anxiety and Depression (assessed by HADS)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Hypnotic Medication Use
timeFrame: Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References: