Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510700
• Other study ID #: GY202201
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: PING YIN
• Phone: 0086-18917561621
• Email: bingxue616[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment remission rate of Insomnia Severity Index (ISI)	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).	Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
Secondary	Sleep Efficiency (SE) with Sleep Diary	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.	At baseline, weeks 1, 2, 3, and 4 (end of treatment)
Secondary	Generalized Anxiety Disorder Scale (GAD-7)	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.	At baseline and week 4 (end of treatment)
Secondary	Patient Health Questionnaire-9 (PHQ-9)	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.	At baseline and week 4 (end of treatment)
Secondary	Quality of Life Core Scale (QLQ-C30)	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.	At baseline and week 4 (end of treatment)
Secondary	Sleep Efficiency (SE) with Actigraphy	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.	At baseline, weeks 1 and 4 (end of treatment)
Secondary	Weekly usage of remedial drugs	The percentage of participants who used emergency drugs.	At weeks 1, 2, 3, and 4 (end of treatment), week 8 (follow-up), and week 16(follow-up)
Secondary	Incidence of adverse events	The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.	During 1-4 weeks
Secondary	Treatment response rate of Insomnia Severity Index (ISI) at follow-up visits	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).	Week 8 (follow-up), and week 16(follow-up)
Secondary	The mean changes of Insomnia Severity Index (ISI) from baseline	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), week 8 (follow-up), and week 16(follow-up)
Secondary	Sleep Awakening (SA) with Actigraphy	It is the number of sleep awakenings during the night that recorded with actigraphy device (wGT3X-BT. LLC, Pensacola, USA).	At baseline, weeks 1 and 4 (end of treatment)
Secondary	Average Awaken Time (AA) with Actigraphy	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).	At baseline, weeks 1 and 4 (end of treatment)