Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy (BCI)

May 16, 2024 updated by: Prof. Zhang Zhang-Jin, The University of Hong Kong

The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Sham-Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Insomnia is a frequent and disturbing symptom among cancer patients. Studies have found that cancer treatments, particularly chemotherapy, are a major cause of cancer-related insomnia. However, insomnia is under-treated in most breast cancer patients because effective, safe evidence-based treatments are lacking.

Acupuncture has been used for thousands of years to treat various diseases, including insomnia. Our previous research demonstrated the efficacy and safety of acupuncture as a treatment for insomnia. However, the effect of acupuncture on insomnia in breast cancer patients who undergo chemotherapy has been rarely studied. We propose this randomized controlled trial to examine the feasibility, effect and safety of acupuncture as a treatment for insomnia in breast cancer patients who undergo chemotherapy.

Hypothesis: We hypothesize that acupuncture is a feasible, effective and safe method for the alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a sham control.

Primary Aim: To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the sham control group, as measured by the ISI after 6 weeks of treatment.

Secondary Aims: 1) To determine whether other sleep-related parameters in the acupuncture group improve more than those of the control group, as measured at different time points by Actiwatch, sleep diary, Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI) and Brief Pain Inventory (BPI). 2) To assess by adverse event (AE) analysis whether acupuncture is safe for treatment of insomnia in breast cancer patients undergoing chemotherapy.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Department of Clinical Oncology, Queen Mary Hospital
      • Hong Kong, Hong Kong, 999077
        • Hong Kong Sanatorium & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: True acupuncture group
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)

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.
Placebo Comparator: Sham acupuncture group
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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actiwatch
Time Frame: Baseline, 6 week.
The subjects will wear Actiwatch for 1 week at baseline period and the end of 6-week treatment.
Baseline, 6 week.
Sleep diary
Time Frame: Baseline, 6 week.
Subjects will be given daily sleep diary for 1 week at baseline period and the end of 6-week treatment.
Baseline, 6 week.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
The PSQI is a reliable and valid self-reported questionnaire that assesses sleep quality over 1 month.
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
The HADS, a 14-item self-rated questionnaire, evaluates the severity of depressive and anxiety symptoms.
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
The BFI is a brief screening tool designed to assess the severity and impact of cancer-related fatigue on daily functioning.
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Brief Fatigue Inventory (BPI)
Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
The BPI is a self-administered questionnaire designed to assess cancer pain.
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
Time Frame: Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.
The FACT-B is a patient-reported outcome measure used to assess health-related quality of life in breast cancer patients.
Baseline, 3 week, 6 week, 10 week, 14 week, 18 week, 30 week, 42 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Zhang-Jin ZHANG, MMed, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 19-045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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