The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy

April 24, 2022 updated by: Professor LAO Lixing, The University of Hong Kong

The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study

This pilot study is designed to determine whether acupuncture is a feasible, effective and safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in breast cancer patients undergoing chemotherapy as compared with a wait-list control.

Objective:

To determine whether the insomnia condition in the acupuncture group is significantly improved when compared to the wait-list control group.

Design and strategy:

This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list control. All patients in the 2 groups will receive routine Western medical care for symptom management.

Study instrument:

Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.

Intervention:

In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list control group, no treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as treatment group.

Main outcome measures:

Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.

Secondary outcomes:

Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer Therapy-Breast Cancer, and adverse events will be documented and compared between groups.

Data analysis: The primary endpoint will be the continuous ISI score. For the primary analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test on the average ISI score will be performed to access the significance of the treatment effects; otherwise, a nonparametric approach will be taken.

Expected outcome: ISI score of the acupuncture group is expected to be significantly lower than wait-list control group after 6 weeks of treatment.

Study Type

Interventional

Enrollment (Actual)

30

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
        • Queen Mary 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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients between 18 and 75 years of age;
  2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
  3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
  4. Insomnia onset after the diagnosis of breast cancer;
  5. 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;
  6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;
  7. Expected survival time of more than 6 months;
  8. Ability to understand the nature of the study and willingness to give informed consent;
  9. Ability to provide responses during outcome measurement.

Exclusion Criteria:

  1. Insomnia before the diagnosis of breast cancer;
  2. Other sleep disorder (e.g., obstructive sleep apnoea);
  3. Shift work or irregular sleep pattern;
  4. Severe visual, hearing or language defects;
  5. Severe hematological dysfunction (platelet count <60,000/μL, haemoglobin <8 g/dL or absolute neutrophil count <1000/μL);
  6. With pacemakers or other electronic implants that could interfere with electroacupuncture;
  7. History of acupuncture use in the previous 3 months;
  8. 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electroacupuncture (EA) and Auricular Acupuncture (AA)
12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.
Device: Acupuncture
Electroacupuncture (EA) and Auricular Acupuncture (AA)
NO_INTERVENTION: Wait-list control
No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Insomnia Severity Index (ISI)
Time Frame: week 0, 3, 6 (primary outcome), 10, 14
week 0, 3, 6 (primary outcome), 10, 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Pittsburgh Sleep Quality Index
Time Frame: week 0, 3, 6, 10, 14
week 0, 3, 6, 10, 14
Sleep diary
Time Frame: week 0, 6
week 0, 6
Actigraphy
Time Frame: week 0, 6
week 0, 6
Functional Assessment of Cancer Therapy-Breast Cancer
Time Frame: week 0, 6, 10, 14
week 0, 6, 10, 14
Adverse events
Time Frame: week 0 to week 6
week 0 to week 6

Collaborators and Investigators

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

Sponsor

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)

March 26, 2019

Primary Completion (ACTUAL)

June 9, 2020

Study Completion (ACTUAL)

October 31, 2020

Study Registration Dates

First Submitted

December 2, 2018

First Submitted That Met QC Criteria

December 2, 2018

First Posted (ACTUAL)

December 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 24, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 18-526

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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