Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer

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.

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)