Clinical trial NCT05510700: Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia
Official title: Acupuncture for Breast Cancer-related Insomnia : a Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Insomnia
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2022-08-22
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Treatment response rate of Insomnia Severity Index (ISI)
timeFrame: Week 4 (end of treatment)
Secondary outcomes:
measure: Treatment remission rate of Insomnia Severity Index (ISI)
timeFrame: Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
measure: Sleep Efficiency (SE) with Sleep Diary
timeFrame: At baseline, weeks 1, 2, 3, and 4 (end of treatment)
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: At baseline and week 4 (end of treatment)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At baseline and week 4 (end of treatment)
measure: Quality of Life Core Scale (QLQ-C30)
timeFrame: At baseline and week 4 (end of treatment)
measure: Sleep Efficiency (SE) with Actigraphy
timeFrame: At baseline, weeks 1 and 4 (end of treatment)
measure: Weekly usage of remedial drugs
timeFrame: At weeks 1, 2, 3, and 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
measure: Incidence of adverse events
timeFrame: During 1-4 weeks
measure: Treatment response rate of Insomnia Severity Index (ISI) at follow-up visits
timeFrame: Week 8 (follow-up), and week 16(follow-up)
measure: The mean changes of Insomnia Severity Index (ISI) from baseline
timeFrame: Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
measure: Sleep Awakening (SA) with Actigraphy
timeFrame: At baseline, weeks 1 and 4 (end of treatment)
measure: Average Awaken Time (AA) with Actigraphy
timeFrame: At baseline, weeks 1 and 4 (end of treatment)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: YUELAI CHEN
role: PRINCIPAL_INVESTIGATOR
References:
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