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Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer

NCT06964945 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

  • Breast Cancer Sleep Disorders Sleep Disturbance Insomnia

Interventions

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.

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964945 on ClinicalTrials.gov