Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy

NCT04144309 | Completed DMC

• 1 other identifier: UW 19-045
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.

Conditions

Insomnia, Secondary; Breast Cancer Female; Chemotherapy

Keywords

Acupuncture; Insomnia; Breast cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  The primary outcome will be the change of ISI score between the baseline and the end of the 6-week treatment. The ISI is a seven-item questionnaire devised to diagnose and assess the severity of insomnia.

  Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

Secondary Outcomes (7)

• Actiwatch

  Baseline, 6 week.

• Sleep diary

  Baseline, 6 week.

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

• Hospital Anxiety and Depression Scale (HADS)

  Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

• Brief Pain Inventory-Short Form (BPI-SF)

  Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

Study Arms (2)

True acupuncture group

ACTIVE COMPARATOR

12 sessions of acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.

Procedure: Electroacupuncture (EA) and Auricular Acupressure (AA)

Sham acupuncture group

PLACEBO COMPARATOR

12 sessions of sham acupuncture treatment (SE+SA) will be given twice a week for 6 weeks after randomization, followed by once a month for 3 months, for a total of 15 sessions of treatments.

Procedure: Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)

Interventions

Electroacupuncture (EA) and Auricular Acupressure (AA) PROCEDURE

EA: Ten points will be used, including GV24 (Shenting), GV20 (Baihui), EX-HN1 (Sishenchong), PC6 (Neiguan), CV12 (Zhongwan), CV4 (Guanyuan), ST25 (Tianshu), ST36 (Zusanli), SP6 (Sanyinjiao), KI3 (Taixi). AA: Vaccaria seeds will be embedded by acupuncturists on three auricular points (Shenmen, Sympathetic and Heart) and maintained between EA treatments.

True acupuncture group

Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA) PROCEDURE

SE: The sham acupuncture treatment procedure, including the acupoint selection principle, sterilization procedure and treatment schedule, will be the same as in the acupuncture treatment group, except that sham points 1 to 2 cm exterior and inferior to the real points will be used, and no needle penetration or electric stimulation will be performed. SA: Three sham auricular points in the helix region (HX7, HX8, HX9) will be selected. Instead of Vaccaria seeds, soft Junci Medulla (1 to 2 mm in length, dyed black) will be used to mimic real AA with no pressure.

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:

• Female patients between 18 and 75 years of age.
• Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer.
• Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months.
• Insomnia onset after the diagnosis of breast cancer.
• Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks.
• Expected survival time of more than 6 months.
• Ability to understand the nature of the study and willingness to give informed consent.
• Ability to provide responses during outcome measurement.

You may not qualify if:

• Other sleep disorder (e.g., obstructive sleep apnoea).
• Shift work or irregular sleep pattern.
• Severe visual, hearing or language defects.
• Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL).
• History of acupuncture use in the previous 3 months.
• Participation in other clinical trials with intervention within 3 months of the beginning of the trial.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, 999077, Hong Kong

Location

Hong Kong Sanatorium & Hospital

Hong Kong, 999077, Hong Kong

Location

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• Mao H, Jin M, Xie L, Mao N, Shen X, Chen J, Chen X, Mao JJ, Shen X. Infrared laser moxibustion for cancer-related fatigue in breast cancer survivors: a randomized controlled trial. Breast Cancer Res. 2024 May 21;26(1):80. doi: 10.1186/s13058-024-01838-1.

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• Zhang J, Qin Z, So TH, Chang TY, Yang S, Chen H, Yeung WF, Chung KF, Chan PY, Huang Y, Xu S, Chiang CY, Lao L, Zhang ZJ. Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial. Breast Cancer Res. 2023 Apr 26;25(1):49. doi: 10.1186/s13058-023-01645-0.

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Breast Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhang-Jin ZHANG, MMed, PhD

  The University of Hong Kong

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: November 18, 2019
• Primary Completion: January 30, 2022
• Study Completion: July 30, 2022
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

HK (2)