Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

NCT05510700 | Active Not Recruiting DMC

• 1 other identifier: GY202201
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Insomnia

Outcome Measures

Primary Outcomes (1)

• Treatment response rate of Insomnia Severity Index (ISI)

  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).

  Week 4 (end of treatment)

Secondary Outcomes (12)

• Treatment remission rate of Insomnia Severity Index (ISI)

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

• Sleep Efficiency (SE) with Sleep Diary

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

• Generalized Anxiety Disorder Scale (GAD-7)

  At baseline and week 4 (end of treatment)

• Patient Health Questionnaire-9 (PHQ-9)

  At baseline and week 4 (end of treatment)

• Quality of Life Core Scale (QLQ-C30)

  At baseline and week 4 (end of treatment)

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Participants will be given sleep hygiene instructions. Participants will receive acupuncture treatment at Nei Guan (PC 6), Shen Men (HT 7), Shen Ting (GV 24), Yin Tang (GV 29), Zhong Wan (CV 12), San Yin Jiao (SP 6), Zhao Hai (KI 6), and Shen Mai (BL 62). Among the above acupoints, Nei Guan (PC 6), Shen Men (HT 7), San Yin Jiao (SP 6), Zhao Hai (KI 6), and Shen Mai (BL 62) are all taken from both sides. Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 12 sessions over the course of four weeks. The follow-up observation will be recorded on week 8 and 16.

Device: Acupuncture

Sham acupuncture group

SHAM COMPARATOR

Participants will be given sleep hygiene instructions. To match the true acupuncture points, sham treatment at sham Nei Guan (PC 6), Shen Men (HT 7), Shen Ting (GV 24), Yin Tang (GV 29), Zhong Wan (CV 12), San Yin Jiao (SP 6), Zhao Hai (KI 6), and Shen Mai (BL 62) will be used. Participants will have the same needle retention time, treatment time, and follow-up time as the acupuncture group.

Device: Sham acupuncture

Interventions

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.

Acupuncture group

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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yin Ping: lead
• Longhua Hospital: collaborator

Study Sites (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (7)

• Morin CM, Edinger JD, Beaulieu-Bonneau S, Ivers H, Krystal AD, Guay B, Belanger L, Cartwright A, Simmons B, Lamy M, Busby M. Effectiveness of Sequential Psychological and Medication Therapies for Insomnia Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Nov 1;77(11):1107-1115. doi: 10.1001/jamapsychiatry.2020.1767.

  PMID: 32639561 BACKGROUND

• Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.

  PMID: 22294820 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Cocks K, King MT, Velikova G, de Castro G Jr, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur J Cancer. 2012 Jul;48(11):1713-21. doi: 10.1016/j.ejca.2012.02.059. Epub 2012 Mar 12.

  PMID: 22418017 BACKGROUND

• Meltzer LJ, Montgomery-Downs HE, Insana SP, Walsh CM. Use of actigraphy for assessment in pediatric sleep research. Sleep Med Rev. 2012 Oct;16(5):463-75. doi: 10.1016/j.smrv.2011.10.002. Epub 2012 Mar 15.

  PMID: 22424706 BACKGROUND

• Yin P, Fan Q, Liu L, Yang M, Zhang S, Li X, Hou W, Feng Q, Wang X, Jin Z, Li F, Chen Y. Efficacy of acupuncture treatment for breast cancer-related insomnia: study protocol for a multicenter randomized controlled trial. Front Psychiatry. 2024 May 23;15:1301338. doi: 10.3389/fpsyt.2024.1301338. eCollection 2024.

  PMID: 38846918 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• YUELAI CHEN

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 22, 2022
• Study Start: October 20, 2022
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)