Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer
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- Who runs it
- Chang Gung Memorial Hospital
- Trial code
- NCT06964945
- Record updated
- 11 May 2025
- Original description
AbstractRead full original descriptionShow less
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.
Inclusion: 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: 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).