Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

Trial Title: Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

NCT ID: NCT05510700

Condition: Breast Neoplasms
Insomnia

Conditions: Official terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Acupuncture
Description: 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.
Arm group label: Acupuncture group

Intervention type: Device
Intervention name: Sham acupuncture
Description: 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.
Arm group label: Sham acupuncture group

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.

Detailed description: Insomnia associated with breast cancer is one of the most common symptoms among breast cancer patients, which seriously affects the life quality of breast cancer patients. Therefore, how to better improve their life quality and insomnia symptoms is of important clinical significance. Previous studies have shown that acupuncture may be beneficial for improving sleep disorders in cancer patients. However, the available clinical evidence is mixed, and clinical studies on acupuncture for breast cancer-associated insomnia lack well-designed, high-quality clinical evidence. The purpose of this study was to evaluate the clinical efficacy and safety of acupuncture for breast cancer-associated insomnia.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Longhua Hospital Shanghai University of Traditional Chinese Medicine

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: YUELAI CHEN

Phone: 0086-13020193726
Email: chenyuelai@163.com

Start date: October 20, 2022

Completion date: June 2025

Lead sponsor:
Agency: Shanghai University of Traditional Chinese Medicine
Agency class: Other

Collaborator:
Agency: Longhua Hospital
Agency class: Other

Source: Shanghai University of Traditional Chinese Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05510700