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Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

Primary Purpose

Breast Neoplasms, Insomnia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Acupuncture

Sham acupuncture

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture group

Sham acupuncture group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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.

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.

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.

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.

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.

Weekly usage of remedial drugs

The percentage of participants who used emergency drugs.

Incidence of adverse events

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

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).

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).

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).

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).

Full Information

NCT ID

NCT05510700

First Posted

August 9, 2022

Last Updated

October 25, 2022

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05510700

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2022 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms, Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture group

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Acupuncture

Intervention 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.

Intervention Type

Device

Intervention Name(s)

Sham acupuncture

Intervention 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.

Primary Outcome Measure Information:

Title

Treatment response rate of Insomnia Severity Index (ISI)

Description

Time Frame

Week 4 (end of treatment)

Secondary Outcome Measure Information:

Title

Treatment remission rate of Insomnia Severity Index (ISI)

Description

Time Frame

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

Title

Sleep Efficiency (SE) with Sleep Diary

Description

Time Frame

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

Title

Generalized Anxiety Disorder Scale (GAD-7)

Description

Time Frame

At baseline and week 4 (end of treatment)

Title

Patient Health Questionnaire-9 (PHQ-9)

Description

Time Frame

At baseline and week 4 (end of treatment)

Title

Quality of Life Core Scale (QLQ-C30)

Description

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.

Time Frame

At baseline and week 4 (end of treatment)

Title

Sleep Efficiency (SE) with Actigraphy

Description

Time Frame

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

Title

Weekly usage of remedial drugs

Description

The percentage of participants who used emergency drugs.

Time Frame

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

Title

Incidence of adverse events

Description

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

Time Frame

During 1-4 weeks

Title

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

Description

Time Frame

Week 8 (follow-up), and week 16(follow-up)

Title

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

Description

Time Frame

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

Title

Sleep Awakening (SA) with Actigraphy

Description

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

Time Frame

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

Title

Average Awaken Time (AA) with Actigraphy

Description

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).

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

PING YIN

Phone

0086-18917561621

bingxue616@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

YUELAI CHEN

Phone

0086-13020193726

chenyuelai@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

YUELAI CHEN

Organizational Affiliation

Shanghai University of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Longhua Hospital Shanghai University of Traditional Chinese Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YUELAI CHEN

Phone

0086-13020193726

chenyuelai@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32639561

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.

Results Reference

background

PubMed Identifier

22294820

Citation

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.

Results Reference

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PubMed Identifier

16717171

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.

Results Reference

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PubMed Identifier

11556941

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.

Results Reference

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PubMed Identifier

22418017

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.

Results Reference

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PubMed Identifier

22424706

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.

Results Reference

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Efficacy of Acupuncture Treatment for Breast Cancer-associated Insomnia

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