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NCT Number: NCT05510700

Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Neoplasms Breast Diseases Dyssomnias Insomnia Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture

Device

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

Device

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.

Primary outcomes

  1. Treatment response rate of Insomnia Severity Index (ISI)

    Time frame: 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).

Secondary outcomes

  1. Treatment remission rate of Insomnia Severity Index (ISI)

    Time frame: Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)

    The percentage of people with a total score of <8 points in total Insomnia Severity Index (ISI) score at the end of week 4, 8 and 16 of 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).

  2. Sleep Efficiency (SE) with Sleep Diary

    Time frame: At baseline, weeks 1, 2, 3, and 4 (end of treatment)

    It will be determined by sleep diary subjectively. Sleep Efficiency(SE) is the percentage of time spent asleep while in bed. It is calculated by (TST / TIB) × 100%. Sleep parameters measured by sleep diary include Sleep Onset Latency (SOL),Wake After Sleep Onset(WASO),Early morning awakening(EMA), and Total Time in Bed (TIB). Total Sleep Time (TST) is calculated by subtracting SOL, WASO and EMA from TIB.

  3. Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: At baseline and week 4 (end of treatment)

    It is a concise anxiety self-assessment instrument consisting of 7 items to assess patients' anxiety over the past two weeks. This questionnaire has a score of 0-3 for each entry and a total score of 21. The scores are 5-9 for mild anxiety, 10-14 for moderate anxiety, and 15-21 for severe anxiety.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: At baseline and week 4 (end of treatment)

    It is a simple and validated 9-item depression self-assessment tool that assesses patients' depression over the past 2 weeks. Each item is scored 0-3, with a total score of 27. Among them, 5-9 are mild depression, 10-14 are moderate depression, 15-19 are severe depression, and 20-27 are very severe depression.

  5. Quality of Life Core Scale (QLQ-C30)

    Time frame: At baseline and week 4 (end of treatment)

    It contains 30 entries with six dimensions. Widely used in clinical studies, it is currently used to assess the quality of life situation of patients.

  6. Sleep Efficiency (SE) with Actigraphy

    Time frame: At baseline, weeks 1 and 4 (end of treatment)

    The actigraphy device (wGT3X-BT. LLC, Pensacola, USA) can monitor sleep quality objectively. Sleep Efficiency(SE) is the percentage of time spent asleep while in bed. It is calculated by (TST / TIB) × 100%. The actigraphy device record Sleep Onset Latency (SOL),Wake After Sleep Onset(WASO), Early morning awakening(EMA), and Total Time in Bed (TIB). Total Sleep Time (TST) is calculated by subtracting SOL, WASO and EMA from TIB.

  7. Weekly usage of remedial drugs

    Time frame: At weeks 1, 2, 3, and 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)

    The percentage of participants who used emergency drugs.

  8. Incidence of adverse events

    Time frame: During 1-4 weeks

    The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.

  9. Treatment response rate of Insomnia Severity Index (ISI) at follow-up visits

    Time frame: Week 8 (follow-up), and week 16(follow-up)

    The percentage of people whose total Insomnia Severity Index (ISI) score decreased by ≥8 points at the end of week 8 and 16 of the 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).

  10. The mean changes of Insomnia Severity Index (ISI) from baseline

    Time frame: Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)

    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).

  11. Sleep Awakening (SA) with Actigraphy

    Time frame: At baseline, weeks 1 and 4 (end of treatment)

    It is the number of sleep awakenings during the night that recorded with actigraphy device (wGT3X-BT. LLC, Pensacola, USA).

  12. Average Awaken Time (AA) with Actigraphy

    Time frame: At baseline, weeks 1 and 4 (end of treatment)

    It is estimated by (Wake After Sleep Onset(WASO) / Sleep Awakening(SA)) measured in minutes that recorded with actigraphy device (wGT3X-BT. LLC, Pensacola, USA).

Sponsors and collaborators

Lead sponsor

Yin Ping

Other

Collaborators

  • Longhua Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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