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Clinical Trials in China / NCT05510700
Active, not recruiting Not applicable

Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

NCT05510700 · tracked via the Priya Life Science China tracker
Sponsor
Yin Ping
Phase
Not applicable
Started
2022-10-20
Last updated
2025-05-22

Condition(s) studied

Breast NeoplasmsInsomnia

Investigational drug(s) / intervention(s)

AcupunctureSham acupuncture

Acupuncture: All acupuncture locations will be sterilized on a routine basis. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate de qi, a sensation generally associated with acupuncture, including swelling, soreness, numbness, and heaviness.

Sham acupuncture: The placebo needles selected for this study are flat-tipped needles without a tip that cannot be pierced into the skin. Also, an external patch device will hold the needles in place and these needles are visually pierced into the skin. At the end of the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball to allow the patient to feel the "needles" being pulled out.

Study summary

Through a scientific and standardized multicenter, randomized, and controlled study method, the investigators evaluated the clinical efficacy and safety of acupuncture in the treatment of breast cancer-related insomnia, with a view to providing a reliable theoretical basis for the treatment of breast cancer-related insomnia with acupuncture.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Meet the diagnostic criteria for breast cancer in the 2022 V2 edition of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (8th edition) for breast cancer staging criteria meet the diagnostic criteria for breast cancer with TNM stage I to III; meet the diagnostic criteria for insomnia within the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and insomnia related to the cancer itself or to cancer-related treatment occurred after breast cancer diagnosis and lasted for at least 1 month. * Female patients aged 18-75 years. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Sleep severity index scale (ISI) score ≥ 8. * Predicted survival of ≥ 6 months. * Patients had never received acupuncture treatment. * No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment. * Consent to participate in this study and sign a written informed consent. Exclusion Criteria: * Combination of more serious heart, liver, kidney, and other major diseases. f applicable, indicate if participant eligibility is based on self-representation of gender identity. * Patients who are pregnant or breastfeeding. * Those with planned surgery during the trial. * Previous history of drug abuse or addiction. * Those who have taken sedative-hypnotic drugs or antipsychotic drugs 2 weeks prior to the baseline visit, or received other treatment for insomnia (e.g., cognitive behavioral therapy, etc.) 3 months prior to the baseline visit, which may affect the efficacy of the observation. * Insomnia due to cancer pain with an numeric rating scale (NRS) score ≥ 4, or insomnia due to other physical diseases. * Long-term night work or irregular rest and relaxation. * Ulcers, abscesses, skin infections, etc. at the site of needling. * Participation in other clinical medical trial studies within the last month.

Primary outcome measure(s)

  • Treatment response rate of Insomnia Severity Index (ISI) — Week 4 (end of treatment)
    The percentage of people whose total Insomnia Severity Index (ISI) score decreased by ≥8 points at the end of week 4 treatment compared to the baseline score. The ISI consists of 7 items to assess the nature and symptoms of the subject's sleep disorders. Questions addressed subjects' subjective ratings of sleep quality, including the severity of symptoms, subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functioning, subjects' awareness of the impact of insomnia on themselves, and their level of frustration due to their sleep disorders. The scores were 0 to 4, with a total score range from 0 to 28. Higher scores indicate more severe insomnia. ISI levels can be classified as no clinically significant insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21), and severe insomnia (22 to 28).

Trial sites (1)

FacilityCityRegionStatus
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai Shanghai Municipality

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Other trials for the same condition

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Health Belief Model-Based Survey on Breast Self-Examination Awareness and Practice Among Community-Dwelling Middle-Aged and Older Women Active, not recruiting
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial Recruiting
Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer Recruiting
Aerobic Dance During Chemotherapy in Breast Cancer Patients With Cognitive Impairment Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05510700 on ClinicalTrials.gov ↗ ← All trials in China