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ACTIVE NOT RECRUITING

NCT05510700

Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

Sponsor: Yin Ping

View on ClinicalTrials.gov

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.

Official title: Acupuncture for Breast Cancer-related Insomnia : a Multicenter Randomized Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2022-10-20

Completion Date

2025-06-01

Last Updated

2025-05-22

Healthy Volunteers

Conditions

Breast Neoplasms Insomnia

Interventions

DEVICE

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.

DEVICE

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.

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.

Locations (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China